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 October 05, 2026

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.
Center For Measurement Standards of Industrial
COLA, Inc.
Global Quality and Regulatory Services
Regulatory Technology Services, LLC
Scarlet NB B.V
SMO India
Third Party Review Group, LLC
PanelSection Number       Regulation Name / Device Name      Class
Anesthesiology
  868.1075 Argon gas analyzer. II
  868.2375 Breathing frequency monitor. II
  868.2385 Nitrogen dioxide analyzer. II
  868.2775 Electrical peripheral nerve stimulator. II
  868.5895 Continuous ventilator. II
  868.5905 Noncontinuous ventilator (IPPB). II
PanelSection Number       Regulation Name / Device Name      Class
Clinical Chemistry
  862.1345 Glucose test system. II
PanelSection Number       Regulation Name / Device Name      Class
Cardiovascular
  870.1425 Programmable diagnostic computer. II
  870.1435 Single-function, preprogrammed diagnostic computer. II
PanelSection Number       Regulation Name / Device Name      Class
Dental
  872.1745 Laser fluorescence caries detection device. II
PanelSection Number       Regulation Name / Device Name      Class
Ear Nose & Throat
  874.3302 Hearing Aid, Bone Conduction II
PanelSection Number       Regulation Name / Device Name      Class
Gastroenterology
  876.5665 Water purification system for hemodialysis. II
PanelSection Number       Regulation Name / Device Name      Class
Neurology
  882.1835 Physiological signal amplifier. II
  882.1845 Physiological signal conditioner. II
PanelSection Number       Regulation Name / Device Name      Class
Physical Medicine
  890.5525 Iontophoresis device. II
PanelSection Number       Regulation Name / Device Name      Class
Radiology
  892.1715 Full-field digital mammography system. II
PanelSection Number       Regulation Name / Device Name      Class
Toxicology
  862.3035 Amikacin test system. II
  862.3645 Neuroleptic drugs radioreceptor assay test system. II
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