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 September 20, 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.
AABB
BeanStock Ventures
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
COLA, Inc.
Global Quality and Regulatory Services
New York State Department of Health
REGULATORY TECHNOLOGY SERVICES, LLC
SGS North America
THIRD PARTY REVIEW GROUP, LLC
BeanStock Ventures
 
8885 Rio San Diego Dr. #237
San Diego CA 92108    
3P510K@beanstockventures.com
https://beanstockventures.com/services/regulatory-compliance/3p510k/
contact: Eileen Heller
phone:1 833 6882326
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
  868.1400 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
  868.1690 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
  868.1800 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
  868.2375 Breathing frequency monitor. II
  868.2385 Nitrogen dioxide analyzer. II
  868.2600 Airway pressure monitor. II
  868.2775 Electrical peripheral nerve stimulator. II
  868.5270 Breathing system heater. II
  868.5330 Breathing gas mixer. II
  868.5440 Portable oxygen generator. II
  868.5470 Hyperbaric chamber. II
  868.5895 Continuous ventilator. II
  868.5905 Noncontinuous ventilator (IPPB). II
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1340 Urinary glucose (nonquantitative) test system. II
  862.1345 Glucose test system. II
  862.1450 Lactic acid test system. I
  862.1690 Thyroid stimulating hormone test system. II
  862.1810 Vitamin B[bdi1][bdi2] test system. II
PanelSection Number       Regulation Name / Device Name      Class
Cardiovascular
  870.1100 Blood pressure alarm. II
  870.1110 Blood pressure computer. II
  870.1130 Noninvasive blood pressure measurement system. II
  870.1425 Programmable diagnostic computer. II
  870.1435 Single-function, preprogrammed diagnostic computer. II
  870.2060 Transducer signal amplifier and conditioner. II
  870.2100 Cardiovascular blood flowmeter. II
  870.2300 Cardiac monitor (including cardiotachometer and rate alarm). II
  870.2320 Ballistocardiograph. II
  870.2340 Electrocardiograph. II
  870.2350 Electrocardiograph lead switching adaptor. II
  870.2370 Electrocardiograph surface electrode tester. II
  870.2770 Impedance plethysmograph. II
  870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs. 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
  870.2910 Radiofrequency physiological signal transmitter and receiver. II
  870.2920 Telephone electrocardiograph transmitter and receiver. II
  870.3640 Indirect pacemaker generator function analyzer. II
  870.3720 Pacemaker electrode function tester. II
  870.4410 Cardiopulmonary bypass in-line blood gas sensor. II
PanelSection Number       Regulation Name / Device Name      Class
Dental
  872.1745 Laser fluorescence caries detection device. II
  872.1800 Extraoral source x-ray system. II
  872.1830 Cephalometer. II
  872.4200 Dental handpiece and accessories. I
  872.4850 Ultrasonic scaler. II
  872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. II
  872.6070 Ultraviolet activator for polymerization. II
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
  874.4760 Nasopharyngoscope (flexible or rigid) and accessories. II
PanelSection Number       Regulation Name / Device Name      Class
Gastroenterology
  876.1500 Endoscope and accessories. II
  876.5320 Nonimplanted electrical continence device. II
  876.5665 Water purification system for hemodialysis. II
PanelSection Number       Regulation Name / Device Name      Class
Hematology
  864.5200 Automated cell counter. II
  864.5220 Automated differential cell counter. II
  864.5260 Automated cell-locating device. II
  864.5680 Automated heparin analyzer. II
  864.6550 Occult blood test. II
  864.7010 Flow Cytometric Test System For Hematopoietic Neoplasms II
PanelSection Number       Regulation Name / Device Name      Class
General Hospital
  880.2910 Clinical electronic thermometer. II
  880.5130 Infant radiant warmer. II
  880.5400 Neonatal incubator. II
  880.5410 Neonatal transport incubator. II
  880.6860 Ethylene oxide gas sterilizer. II
  880.6870 Dry-heat sterilizer. II
PanelSection Number       Regulation Name / Device Name      Class
Immunology
  866.5130 Alpha-1-antitrypsin immunological test system. II
  866.5340 Ferritin immunological test system. II
  866.5580 Alpha-1-lipoprotein immunological test system. II
  866.6010 Tumor-associated antigen immunological test system. II
PanelSection Number       Regulation Name / Device Name      Class
Microbiology
  866.2190 Microbial Colony Image Assessment System II
PanelSection Number       Regulation Name / Device Name      Class
Neurology
  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
  882.1620 Intracranial pressure monitoring device. II
  882.1630 Cranial Motion Measurement 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
  882.4400 Radiofrequency lesion generator. II
  882.5810 External functional neuromuscular stimulator. II
  882.5890 Transcutaneous electrical nerve stimulator for pain relief. II
PanelSection Number       Regulation Name / Device Name      Class
Obstetrics/Gynecology
  866.6050 Ovarian adnexal mass assessment score test system. II
  884.1630 Colposcope. 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
  884.4120 Gynecologic electrocautery and accessories. II
PanelSection Number       Regulation Name / Device Name      Class
Ophthalmic
  886.1120 Ophthalmic camera. II
  886.1510 Eye movement monitor. II
  886.1570 Ophthalmoscope. II
  886.1850 AC-powered slitlamp biomicroscope. II
  886.1930 Tonometer and accessories. II
PanelSection Number       Regulation Name / Device Name      Class
Pathology
  864.3700 Digital Pathology Display II
  866.6080 Next generation sequencing based tumor profiling test. II
PanelSection Number       Regulation Name / Device Name      Class
Physical Medicine
  890.5300 Ultrasonic diathermy. II
  890.5525 Iontophoresis device. II
  890.5850 Powered 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
  892.1170 Bone densitometer. II
  892.1200 Emission computed tomography system. II
  892.1570 Diagnostic ultrasonic transducer. II
  892.1630 Electrostatic x-ray imaging system. II
  892.1650 Image-intensified fluoroscopic x-ray system. II
  892.1710 Mammographic x-ray system. II
  892.1715 Full-field digital mammography 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
  878.4400 Electrosurgical cutting and coagulation device and accessories. II
PanelSection Number       Regulation Name / Device Name      Class
Toxicology
  862.3035 Amikacin test system. II
  862.3100 Amphetamine test system. II
  862.3350 Diphenylhydantoin test system. II
  862.3360 Drug metabolizing enzyme genotyping system. II
  862.3580 Lysergic acid diethylamide (LSD) test system. II
  862.3630 Methaqualone test system. II
  862.3645 Neuroleptic drugs radioreceptor assay test system. II
  862.3880 Theophylline test system. II
  862.3950 Vancomycin test system. II
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