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 April 05, 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.
Accelerated Device Approval Services
BeanStock Ventures
COLA, Inc.
Global Quality and Regulatory Services
New York State Department of Health
SGS North America
BeanStock Ventures
8885 Rio San Diego Dr. #237
San Diego CA 92108
contact: Eileen Heller
phone:1 833 6882326
PanelSection Number       Regulation Name / Device Name      Class
  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
  868.5330 Breathing gas mixer. II
  868.5440 Portable oxygen generator. II
  868.5470 Hyperbaric chamber. II
PanelSection Number       Regulation Name / Device Name      Class
  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
  870.2300 Cardiac monitor (including cardiotachometer and rate alarm). II
  870.2320 Ballistocardiograph. II
  870.2340 Electrocardiograph. II
  870.2350 Electrocardiograph lead switching adaptor. II
  870.2850 Extravascular blood pressure transducer. II
PanelSection Number       Regulation Name / Device Name      Class
  872.1800 Extraoral source x-ray system. 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
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