Current List of FDA-Recognized 510(k) Third Party Review Organizations
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U.S. Department of Health and Human Services

Current List of FDA-Recognized 510(k) Third Party Review Organizations

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Database updated November 29, 2021

This page provides information on organizations recognized by FDA to review submissions under the 510(k) Third Party Review Program (formally, the Accredited Persons Program) and the devices they may review. Product codes eligible to review by a specific 3P510k Review Organization are listed under the following regulations. Devices eligible for review by 3P510k Review Organizations are limited to the product codes shown on the list of eligible devices. You can look up a given product code in the product code database, browse by 3P510k review organization in the list below or browse by device area to confirm eligibility of your device.

As of August 13, 2021, Accelerated Device Approval Services, LLC (ADAS) is no longer recognized to conduct 510(k) Third Party Reviews. For details, see the Accreditation Status section on the 510(k) Third Party Performance Metrics and Accreditation Status page.
BeanStock Ventures
COLA, Inc.
Global Quality and Regulatory Services
New York State Department of Health
SGS North America
phone:886 357 32227
PanelSection Number       Regulation Name / Device Name      Class
  868.5440 Portable oxygen generator. II
  868.5915 Manual emergency ventilator. II
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1050 Alkaline phosphatase or isoenzymes test system. II
  862.1065 Ammonia test system. I
  862.1110 Bilirubin (total or direct) test system. II
  862.1113 Bilirubin (total and unbound) in the neonate test system. I
  862.1120 Blood gases (PCO2, PO2) and blood pH test system. II
  862.1155 Human chorionic gonadotropin (HCG) test system. II
  862.1160 Bicarbonate/carbon dioxide test system. II
  862.1170 Chloride test system. II
  862.1225 Creatinine test system. II
  862.1310 Galactose test system. I
  862.1340 Urinary glucose (nonquantitative) test system. II
  862.1345 Glucose test system. II
  862.1450 Lactic acid test system. I
  862.1475 Lipoprotein test system. I
  862.1495 Magnesium test system. I
  862.1600 Potassium test system. II
  862.1665 Sodium test system. II
  862.1675 Blood specimen collection device. II
  862.1680 Testosterone test system. I
  862.1690 Thyroid stimulating hormone test system. II
  862.1695 Free thyroxine test system. II
  862.1730 Free tyrosine test system. I
  862.1770 Urea nitrogen test system. II
  862.1775 Uric acid test system. I
  862.1825 Vitamin D test system. II
PanelSection Number       Regulation Name / Device Name      Class
  870.1120 Blood pressure cuff. II
  870.1130 Noninvasive blood pressure measurement system. II
  870.2300 Cardiac monitor (including cardiotachometer and rate alarm). II
  870.2330 Echocardiograph. II
  870.2340 Electrocardiograph. II
  870.2350 Electrocardiograph lead switching adaptor. II
  870.2370 Electrocardiograph surface electrode tester. II
  870.2700 Oximeter. II
  870.2880 Ultrasonic transducer. II
PanelSection Number       Regulation Name / Device Name      Class
  872.1800 Extraoral source x-ray system. II
  872.1810 Intraoral source x-ray system. II
  872.3200 Resin tooth bonding agent. II
  872.3275 Dental cement. II
  872.3660 Impression material. II
  872.3690 Tooth shade resin material. II
  872.4200 Dental handpiece and accessories. I
  872.4850 Ultrasonic scaler. II
  872.6070 Ultraviolet activator for polymerization. II
  872.6250 Dental chair and accessories. I
  872.6640 Dental operative unit and accessories. I
  872.6710 Boiling water sterilizer. I
PanelSection Number       Regulation Name / Device Name      Class
  876.1075 Gastroenterology-urology biopsy instrument. I
  876.1075 Gastroenterology-urology biopsy instrument. II
  876.1500 Endoscope and accessories. 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
  876.5130 Urological catheter and accessories. II
  876.5320 Nonimplanted electrical continence device. 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
PanelSection Number       Regulation Name / Device Name      Class
  864.5220 Automated differential cell counter. II
  864.5425 Multipurpose system for in vitro coagulation studies. II
  864.5700 Automated platelet aggregation system. II
  864.6550 Occult blood test. II
PanelSection Number       Regulation Name / Device Name      Class
General Hospital
  880.2910 Clinical electronic thermometer. II
  880.5090 Liquid bandage. I
  880.5200 Intravascular catheter. II
  880.5400 Neonatal incubator. II
  880.5410 Neonatal transport incubator. II
  880.5440 Intravascular administration set. II
  880.5570 Hypodermic single lumen needle. II
  880.5680 Pediatric position holder. I
  880.5860 Piston syringe. II
  880.6250 Non-powdered patient examination glove. I
  880.6375 Patient lubricant. I
  880.6850 Sterilization wrap. II
  880.6880 Steam sterilizer. II
  880.6885 Liquid chemical sterilants/high level disinfectants. II
PanelSection Number       Regulation Name / Device Name      Class
  866.5270 C-reactive protein immunological test system. II
  866.5340 Ferritin immunological test system. II
  866.5600 Low-density lipoprotein immunological test system. II
  866.5775 Rheumatoid factor immunological test system. II
  866.5880 Transferrin immunological test system. II
PanelSection Number       Regulation Name / Device Name      Class
  866.1620 Antimicrobial susceptibility test disc. II
  866.1640 Antimicrobial susceptibility test powder. II
  866.2390 Transport culture medium. I
  866.2560 Microbial growth monitor. I
  866.2850 Automated zone reader. I
  866.2900 Microbiological specimen collection and transport device. I
  866.3110 Campylobacter fetus serological reagents. I
  866.3120 Chlamydia serological reagents. I
  866.3235 Epstein-Barr virus serological reagents. I
  866.3370 Mycobacterium tuberculosis immunofluorescent reagents. I
  866.3870 Trypanosoma spp. serological reagents. I
PanelSection Number       Regulation Name / Device Name      Class
  882.1030 Ataxiagraph. I
  882.1240 Echoencephalograph. II
  882.1310 Cortical electrode. II
  882.1320 Cutaneous electrode. II
  882.1400 Electroencephalograph. II
  882.1420 Electroencephalogram (EEG) signal spectrum analyzer. I
  882.5890 Transcutaneous electrical nerve stimulator for pain relief. II
PanelSection Number       Regulation Name / Device Name      Class
  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
  884.2660 Fetal ultrasonic monitor and accessories. II
  884.2960 Obstetric ultrasonic transducer and accessories. II
  884.4120 Gynecologic electrocautery and accessories. II
  884.4550 Gynecologic surgical laser. II
  884.5300 Condom. II
  884.5310 Condom with spermicidal lubricant. 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
PanelSection Number       Regulation Name / Device Name      Class
  886.1570 Ophthalmoscope. II
  886.1850 AC-powered slitlamp biomicroscope. II
  886.3400 Keratoprosthesis. II
  886.4150 Vitreous aspiration and cutting instrument. II
  886.4300 Intraocular lens guide. I
  886.4370 Keratome. I
  886.4390 Ophthalmic laser. II
  886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy. II
  886.4670 Phacofragmentation system. II
  886.5916 Rigid gas permeable contact lens. II
  886.5918 Rigid gas permeable contact lens care products. II
  886.5925 Soft (hydrophilic) contact lens. II
  886.5928 Soft (hydrophilic) contact lens care products. II
PanelSection Number       Regulation Name / Device Name      Class
Physical Medicine
  890.1385 Diagnostic electromyograph needle electrode. 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
  890.5500 Infrared lamp. II
  890.5710 Hot or cold disposable pack. I
  890.5850 Powered muscle stimulator. II
PanelSection Number       Regulation Name / Device Name      Class
  892.1000 Magnetic resonance diagnostic device. II
  892.1100 Scintillation (gamma) camera. I
  892.1110 Positron camera. I
  892.1200 Emission computed tomography system. II
  892.1310 Nuclear tomography system. II
  892.1360 Radionuclide dose calibrator. 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
  892.1680 Stationary x-ray system. II
  892.1710 Mammographic x-ray system. II
  892.1720 Mobile 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
PanelSection Number       Regulation Name / Device Name      Class
General & Plastic Surgery
  878.4040 Surgical apparel. II
  878.4400 Electrosurgical cutting and coagulation device and accessories. II
  878.4460 Non-powdered surgeon's glove. I
  878.4580 Surgical lamp. II
  878.4780 Powered suction pump. II
  878.4800 Manual surgical instrument for general use. I
  878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology. II
PanelSection Number       Regulation Name / Device Name      Class
  862.3100 Amphetamine test system. II
  862.3110 Antimony test system. I
  862.3120 Arsenic test system. I
  862.3150 Barbiturate test system. II
  862.3250 Cocaine and cocaine metabolite test system. II
  862.3270 Codeine test system. II
  862.3600 Mercury test system. I
  862.3610 Methamphetamine test system. II
  862.3620 Methadone test system. II
  862.3640 Morphine test system. II
  862.3650 Opiate test system. II
  862.3700 Propoxyphene test system. II
  862.3750 Quinine test system. I
  862.3850 Sulfonamide test system. I
  862.3870 Cannabinoid test system. II
  862.3910 Tricyclic antidepressant drugs test system. II
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