Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997
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U.S. Department of Health and Human Services

Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997

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Database Updated 03/23/2020

This page provides information on persons accredited (as of the above date of revision) to review selected premarket notifications [510(k)s] and the devices they may review.  Information on this list will be updated within 10 working days after the date reflected on the third party's accreditation letter.  Each classified device type on the list of devices eligible for Third Party Review has one or more product codes associated with it.  Devices eligible for review by Third Parties are limited to the product codes shown on the list of eligible devices.  Please refer to the List of Devices for Third Party Review Under the FDA Modernization Act (FDAMA) of 1997 to assure your device is eligible for the Accredited Person Program. To-date, FDA has not withdrawn accreditation from any Accredited Person.
AABB
Accelerated Device Approval Services, LLC
Biomarkers and Diagnostics Consulting, LLC
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
New York State Department of Health
REGULATORY TECHNOLOGY SERVICES, LLC
THIRD PARTY REVIEW GROUP, LLC
TUV SUD AMERICA INC.
Accelerated Device Approval Services, LLC
6800 S.W. 40th Street, Ste. 444
Ludlum FL 33155-3708    
Contact: Anna Reifschneider
Phone:1 866 6698370
Fax: 800 3986285
Internet:
http://www.510k-review.com
PanelSection Number       Regulation Name / Device Name      Class
Anesthesiology
  868.1075 Argon gas analyzer. II
  868.1150 Indwelling blood carbon dioxide partial pressure (PCO2) analyzer. II
  868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer. II
  868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer. II
  868.1400 Carbon dioxide gas analyzer. II
  868.1430 Carbon monoxide gas analyzer. II
  868.1500 Enflurane gas analyzer. II
  868.1620 Halothane gas analyzer. II
  868.1640 Helium gas analyzer. II
  868.1670 Neon gas analyzer. II
  868.1690 Nitrogen gas analyzer. II
  868.1700 Nitrous oxide gas analyzer. II
  868.1720 Oxygen gas analyzer. II
  868.1730 Oxygen uptake computer. II
  868.1750 Pressure plethysmograph. II
  868.1760 Volume plethysmograph. II
  868.1780 Inspiratory airway pressure meter. II
  868.1800 Rhinoanemometer. II
  868.1840 Diagnostic spirometer. II
  868.1850 Monitoring spirometer. II
  868.1860 Peak-flow meter for spirometry. II
  868.1880 Pulmonary-function data calculator. II
  868.1890 Predictive pulmonary-function value calculator. II
  868.1900 Diagnostic pulmonary-function interpretation calculator. II
  868.1920 Esophageal stethoscope with electrical conductors. II
  868.2025 Ultrasonic air embolism monitor. II
  868.2375 Breathing frequency monitor. II
  868.2385 Nitrogen dioxide analyzer. II
  868.2600 Airway pressure monitor. II
  868.2775 Electrical peripheral nerve stimulator. II
  868.5090 Emergency airway needle. II
  868.5120 Anesthesia conduction catheter. I
  868.5120 Anesthesia conduction catheter. II
  868.5130 Anesthesia conduction filter. II
  868.5140 Anesthesia conduction kit. II
  868.5150 Anesthesia conduction needle. II
  868.5170 Laryngotracheal topical anesthesia applicator. II
  868.5260 Breathing circuit bacterial filter. II
  868.5270 Breathing system heater. II
  868.5330 Breathing gas mixer. II
  868.5430 Gas-scavenging apparatus. II
  868.5440 Portable oxygen generator. II
  868.5450 Respiratory gas humidifier. II
  868.5470 Hyperbaric chamber. II
  868.5655 Portable liquid oxygen unit. II
  868.5665 Powered percussor. II
  868.5690 Incentive spirometer. II
  868.5730 Tracheal tube. II
  868.5750 Inflatable tracheal tube cuff. II
  868.5800 Tracheostomy tube and tube cuff. II
  868.5870 Nonrebreathing valve. II
  868.5880 Anesthetic vaporizer. II
  868.5895 Continuous ventilator. II
  868.5905 Noncontinuous ventilator (IPPB). II
  868.5915 Manual emergency ventilator. II
PanelSection Number       Regulation Name / Device Name      Class
Cardiovascular
  870.1100 Blood pressure alarm. II
  870.1110 Blood pressure computer. II
  870.1120 Blood pressure cuff. II
  870.1130 Noninvasive blood pressure measurement system. II
  870.1140 Venous blood pressure manometer. II
  870.1200 Diagnostic intravascular catheter. II
  870.1210 Continuous flush catheter. II
  870.1230 Fiberoptic oximeter catheter. II
  870.1240 Flow-directed catheter. II
  870.1250 Percutaneous catheter. II
  870.1270 Intracavitary phonocatheter system. II
  870.1280 Steerable catheter. II
  870.1290 Steerable catheter control system. II
  870.1300 Catheter cannula. II
  870.1310 Vessel dilator for percutaneous catheterization. II
  870.1330 Catheter guide wire. II
  870.1340 Catheter introducer. II
  870.1370 Catheter tip occluder. II
  870.1380 Catheter stylet. II
  870.1390 Trocar. II
  870.1425 Programmable diagnostic computer. II
  870.1435 Single-function, preprogrammed diagnostic computer. II
  870.1450 Densitometer. II
  870.1650 Angiographic injector and syringe. II
  870.1660 Indicator injector. II
  870.1670 Syringe actuator for an injector. II
  870.1800 Withdrawal-infusion pump. II
  870.1875 Stethoscope. II
  870.1915 Thermodilution probe. II
  870.2050 Biopotential amplifier and signal conditioner. II
  870.2060 Transducer signal amplifier and conditioner. II
  870.2100 Cardiovascular blood flowmeter. II
  870.2120 Extravascular blood flow probe. II
  870.2300 Cardiac monitor (including cardiotachometer and rate alarm). II
  870.2310 Apex cardiograph (vibrocardiograph). II
  870.2320 Ballistocardiograph. II
  870.2330 Echocardiograph. II
  870.2340 Electrocardiograph. II
  870.2350 Electrocardiograph lead switching adaptor. II
  870.2370 Electrocardiograph surface electrode tester. II
  870.2400 Vectorcardiograph. II
  870.2450 Medical cathode-ray tube display. II
  870.2750 Impedance phlebograph. II
  870.2770 Impedance plethysmograph. II
  870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs. II
  870.2800 Medical magnetic tape recorder. II
  870.2840 Apex cardiographic transducer. II
  870.2850 Extravascular blood pressure transducer. II
  870.2860 Heart sound transducer. II
  870.2870 Catheter tip pressure transducer. II
  870.2880 Ultrasonic transducer. II
  870.2890 Vessel occlusion transducer. II
  870.2900 Patient transducer and electrode cable (including connector). II
  870.2910 Radiofrequency physiological signal transmitter and receiver. II
  870.2920 Telephone electrocardiograph transmitter and receiver. II
  870.3630 Pacemaker generator function analyzer. II
  870.3640 Indirect pacemaker generator function analyzer. II
  870.3720 Pacemaker electrode function tester. II
  870.4075 Endomyocardial biopsy device. II
  870.4205 Cardiopulmonary bypass bubble detector. II
  870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing. II
  870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter. II
  870.4310 Cardiopulmonary bypass coronary pressure gauge. II
  870.4330 Cardiopulmonary bypass on-line blood gas monitor. II
  870.4390 Cardiopulmonary bypass pump tubing. II
  870.4400 Cardiopulmonary bypass blood reservoir. II
  870.4410 Cardiopulmonary bypass in-line blood gas sensor. II
  870.4450 Vascular clamp. II
  870.4475 Surgical vessel dilator. II
  870.4875 Intraluminal artery stripper. II
  870.4885 External vein stripper. II
  870.5050 Patient care suction apparatus. II
  870.5150 Embolectomy catheter. II
  870.5175 Septostomy catheter. II
  870.5325 Defibrillator tester. II
  870.5800 Compressible limb sleeve. II
  870.5900 Thermal regulating system. II
  870.5925 Automatic rotating tourniquet. II
PanelSection Number       Regulation Name / Device Name      Class
Dental
  872.1740 Caries detection device. II
  872.1800 Extraoral source x-ray system. II
  872.1810 Intraoral source x-ray system. II
  872.1830 Cephalometer. II
  872.1870 Sulfide detection device. II
  872.3070 Dental amalgam, mercury, and amalgam alloy. II
  872.3200 Resin tooth bonding agent. II
  872.3250 Calcium hydroxide cavity liner. II
  872.3260 Cavity varnish. II
  872.3275 Dental cement. II
  872.3310 Coating material for resin fillings. II
  872.3660 Impression material. II
  872.3690 Tooth shade resin material. II
  872.3750 Bracket adhesive resin and tooth conditioner. II
  872.3760 Denture relining, repairing, or rebasing resin. II
  872.3765 Pit and fissure sealant and conditioner. II
  872.3770 Temporary crown and bridge resin. II
  872.3820 Root canal filling resin. II
  872.3920 Porcelain tooth. II
  872.4120 Bone cutting instrument and accessories. II
  872.4200 Dental handpiece and accessories. I
  872.4465 Gas-powered jet injector. II
  872.4475 Spring-powered jet injector. II
  872.4840 Rotary scaler. II
  872.4850 Ultrasonic scaler. II
  872.4920 Dental electrosurgical unit and accessories. II
  872.5470 Orthodontic plastic bracket. II
  872.5500 Extraoral orthodontic headgear. II
  872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. II
  872.6070 Ultraviolet activator for polymerization. II
  872.6080 Airbrush. II
  872.6250 Dental chair and accessories. I
  872.6350 Ultraviolet detector. II
  872.6640 Dental operative unit and accessories. I
  872.6660 Porcelain powder for clinical use. II
  872.6710 Boiling water sterilizer. I
PanelSection Number       Regulation Name / Device Name      Class
Ear Nose & Throat
  874.1090 Auditory impedance tester. II
  874.3300 Hearing Aid. II
  874.3400 Tinnitus masker. II
  874.4250 Ear, nose, and throat electric or pneumatic surgical drill. II
  874.4490 Argon laser for otology, rhinology, and laryngology. II
  874.4500 Ear, nose, and throat microsurgical carbon dioxide laser. II
  874.4680 Bronchoscope (flexible or rigid) and accessories. II
  874.4760 Nasopharyngoscope (flexible or rigid) and accessories. II
PanelSection Number       Regulation Name / Device Name      Class
Gastroenterology
  876.1075 Gastroenterology-urology biopsy instrument. I
  876.1075 Gastroenterology-urology biopsy instrument. II
  876.1500 Endoscope and accessories. II
  876.1725 Gastrointestinal motility monitoring system. II
  876.4300 Endoscopic electrosurgical unit and accessories. II
  876.4480 Electrohydraulic lithotriptor. II
  876.4500 Mechanical lithotriptor. II
  876.4620 Ureteral stent. II
  876.5010 Biliary catheter and accessories. II
  876.5090 Suprapubic urological catheter and accessories. II
  876.5130 Urological catheter and accessories. II
  876.5320 Nonimplanted electrical continence device. II
  876.5470 Ureteral dilator. II
  876.5520 Urethral dilator. II
  876.5540 Blood access device and accessories. I
  876.5540 Blood access device and accessories. II
  876.5665 Water purification system for hemodialysis. II
  876.5820 Hemodialysis system and accessories. II
  876.5880 Isolated kidney perfusion and transport system and accessories. II
  876.5980 Gastrointestinal tube and accessories. II
PanelSection Number       Regulation Name / Device Name      Class
General Hospital
  880.2420 Electronic monitor for gravity flow infusion systems. II
  880.2460 Electrically powered spinal fluid pressure monitor. II
  880.2500 Spinal fluid manometer. II
  880.2800 Sterilization process indicator. II
  880.2910 Clinical electronic thermometer. II
  880.5025 I.V. container. II
  880.5045 Medical recirculating air cleaner. II
  880.5090 Liquid bandage. I
  880.5130 Infant radiant warmer. II
  880.5200 Intravascular catheter. II
  880.5400 Neonatal incubator. II
  880.5410 Neonatal transport incubator. II
  880.5440 Intravascular administration set. II
  880.5450 Patient care reverse isolation chamber. II
  880.5570 Hypodermic single lumen needle. II
  880.5580 Acupuncture needle. II
  880.5680 Pediatric position holder. I
  880.5700 Neonatal phototherapy unit. II
  880.5860 Piston syringe. II
  880.6100 Ethylene oxide gas aerator cabinet. II
  880.6250 Non-powdered patient examination glove. I
  880.6375 Patient lubricant. I
  880.6500 Medical ultraviolet air purifier. II
  880.6850 Sterilization wrap. II
  880.6860 Ethylene oxide gas sterilizer. II
  880.6870 Dry-heat sterilizer. II
  880.6880 Steam sterilizer. II
  880.6885 Liquid chemical sterilants/high level disinfectants. II
PanelSection Number       Regulation Name / Device Name      Class
Neurology
  882.1030 Ataxiagraph. I
  882.1240 Echoencephalograph. II
  882.1275 Electroconductive media. II
  882.1310 Cortical electrode. II
  882.1320 Cutaneous electrode. II
  882.1330 Depth electrode. II
  882.1340 Nasopharyngeal electrode. II
  882.1350 Needle electrode. II
  882.1400 Electroencephalograph. II
  882.1420 Electroencephalogram (EEG) signal spectrum analyzer. I
  882.1460 Nystagmograph. II
  882.1550 Nerve conduction velocity measurement device. II
  882.1570 Powered direct-contact temperature measurement device. II
  882.1610 Alpha monitor. II
  882.1620 Intracranial pressure monitoring device. II
  882.1835 Physiological signal amplifier. II
  882.1845 Physiological signal conditioner. II
  882.1870 Evoked response electrical stimulator. II
  882.1880 Evoked response mechanical stimulator. II
  882.1890 Evoked response photic stimulator. II
  882.1900 Evoked response auditory stimulator. II
  882.1950 Tremor transducer. II
  882.4100 Ventricular catheter. II
  882.4150 Scalp clip. II
  882.4175 Aneurysm clip applier. II
  882.4250 Cryogenic surgical device. II
  882.4275 Dowel cutting instrument. II
  882.4300 Manual cranial drills, burrs, trephines, and their accessories II
  882.4305 Powered compound cranial drills, burrs, trephines, and their accessories. II
  882.4310 Powered simple cranial drills, burrs, trephines, and their accessories. II
  882.4360 Electric cranial drill motor. II
  882.4370 Pneumatic cranial drill motor. II
  882.4400 Radiofrequency lesion generator. II
  882.4460 Neurosurgical head holder (skull clamp). II
  882.4700 Neurosurgical paddie. II
  882.4725 Radiofrequency lesion probe. II
  882.4800 Self-retaining retractor for neurosurgery. II
  882.4840 Manual rongeur. II
  882.4845 Powered rongeur. II
  882.5070 Bite block. II
  882.5235 Aversive conditioning device. II
  882.5500 Lesion temperature monitor. II
  882.5810 External functional neuromuscular stimulator. II
  882.5890 Transcutaneous electrical nerve stimulator for pain relief. II
  882.5960 Skull tongs for traction. II
PanelSection Number       Regulation Name / Device Name      Class
Obstetrics/Gynecology
  884.1050 Endocervical aspirator. II
  884.1060 Endometrial aspirator. II
  884.1100 Endometrial brush. II
  884.1175 Endometrial suction curette and accessories. II
  884.1185 Endometrial washer. II
  884.1300 Uterotubal carbon dioxide insufflator and accessories. II
  884.1560 Fetal blood sampler. II
  884.1630 Colposcope. II
  884.1660 Transcervical endoscope (amnioscope) and accessories. II
  884.1690 Hysteroscope and accessories. II
  884.1700 Hysteroscopic insufflator. II
  884.1720 Gynecologic laparoscope and accessories. II
  884.1730 Laparoscopic insufflator. I
  884.2225 Obstetric-gynecologic ultrasonic imager. II
  884.2600 Fetal cardiac monitor. II
  884.2640 Fetal phonocardiographic monitor and accessories. II
  884.2660 Fetal ultrasonic monitor and accessories. II
  884.2675 Fetal scalp circular (spiral) electrode and applicator. II
  884.2700 Intrauterine pressure monitor and accessories. II
  884.2720 External uterine contraction monitor and accessories. II
  884.2740 Perinatal monitoring system and accessories. II
  884.2960 Obstetric ultrasonic transducer and accessories. II
  884.3575 Vaginal pessary. II
  884.3900 Vaginal stent. II
  884.4120 Gynecologic electrocautery and accessories. II
  884.4160 Unipolar endoscopic coagulator-cutter and accessories. II
  884.4260 Hygroscopic Laminaria cervical dilator. II
  884.4340 Fetal vacuum extractor. II
  884.4500 Obstetric fetal destructive instrument. II
  884.4530 Obstetric-gynecologic specialized manual instrument. II
  884.4550 Gynecologic surgical laser. II
  884.5070 Vacuum abortion system. II
  884.5100 Obstetric anesthesia set. II
  884.5160 Powered breast pump. II
  884.5250 Cervical cap. II
  884.5300 Condom. II
  884.5310 Condom with spermicidal lubricant. II
  884.5350 Contraceptive diaphragm and accessories. II
  884.5460 Scented or scented deodorized menstrual tampon. II
  884.5470 Unscented menstrual tampon. II
  884.6100 Assisted reproduction needles. II
  884.6110 Assisted reproduction catheters. II
  884.6120 Assisted reproduction accessories. II
  884.6130 Assisted reproduction microtools. II
  884.6140 Assisted reproduction micropipette fabrication instruments. II
  884.6160 Assisted reproduction labware. II
  884.6170 Assisted reproduction water and water purification systems. II
PanelSection Number       Regulation Name / Device Name      Class
Physical Medicine
  890.1225 Chronaximeter. II
  890.1375 Diagnostic electromyograph. II
  890.1385 Diagnostic electromyograph needle electrode. II
  890.1850 Diagnostic muscle stimulator. II
  890.3690 Powered wheeled stretcher. II
  890.3800 Motorized three-wheeled vehicle. II
  890.3850 Mechanical wheelchair. I
  890.3860 Powered wheelchair. II
  890.3880 Special grade wheelchair. II
  890.3900 Standup wheelchair. II
  890.3930 Wheelchair elevator. II
  890.5150 Powered patient transport. II
  890.5275 Microwave diathermy. II
  890.5290 Shortwave diathermy. II
  890.5300 Ultrasonic diathermy. II
  890.5500 Infrared lamp. II
  890.5525 Iontophoresis device. II
  890.5650 Powered inflatable tube massager. II
  890.5710 Hot or cold disposable pack. I
  890.5850 Powered muscle stimulator. II
  890.5860 Ultrasound and muscle stimulator. II
  890.5880 Multi-function physical therapy table. II
  890.5900 Power traction equipment. II
PanelSection Number       Regulation Name / Device Name      Class
Radiology
  892.1000 Magnetic resonance diagnostic device. II
  892.1100 Scintillation (gamma) camera. I
  892.1110 Positron camera. I
  892.1170 Bone densitometer. II
  892.1200 Emission computed tomography system. II
  892.1220 Fluorescent scanner. II
  892.1310 Nuclear tomography system. II
  892.1360 Radionuclide dose calibrator. II
  892.1390 Radionuclide rebreathing system. II
  892.1540 Nonfetal ultrasonic monitor. II
  892.1550 Ultrasonic pulsed doppler imaging system. II
  892.1560 Ultrasonic pulsed echo imaging system. II
  892.1570 Diagnostic ultrasonic transducer. II
  892.1620 Cine or spot fluorographic x-ray camera. II
  892.1630 Electrostatic x-ray imaging system. II
  892.1650 Image-intensified fluoroscopic x-ray system. II
  892.1660 Non-image-intensified fluoroscopic x-ray system. II
  892.1680 Stationary x-ray system. II
  892.1710 Mammographic x-ray system. II
  892.1720 Mobile x-ray system. II
  892.1730 Photofluorographic x-ray system. II
  892.1740 Tomographic x-ray system. II
  892.1750 Computed tomography x-ray system. II
  892.2050 Picture archiving and communications system. II
  892.5710 Radiation therapy beam-shaping block. II
  892.5730 Radionuclide brachytherapy source. II
  892.5750 Radionuclide radiation therapy system. II
  892.5770 Powered radiation therapy patient support assembly. II
  892.5840 Radiation therapy simulation system. II
  892.5900 X-ray radiation therapy system. II
  892.5930 Therapeutic x-ray tube housing assembly. II
PanelSection Number       Regulation Name / Device Name      Class
General & Plastic Surgery
  878.4040 Surgical apparel. II
  878.4200 Introduction/drainage catheter and accessories. I
  878.4350 Cryosurgical unit and accessories. II
  878.4370 Surgical drape and drape accessories. II
  878.4400 Electrosurgical cutting and coagulation device and accessories. II
  878.4410 Low energy ultrasound wound cleaner. II
  878.4460 Non-powdered surgeon's glove. I
  878.4580 Surgical lamp. II
  878.4630 Ultraviolet lamp for dermatologic disorders. II
  878.4780 Powered suction pump. II
  878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology. II
  878.5040 Suction lipoplasty system. II
  878.5070 Air-handling apparatus for a surgical operating room. II
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