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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated November 29, 2021

This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.

How to use the list of eligible devices

The list has four columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that fda has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.

Some important exceptions to the list

Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.


Anesthesiology

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Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
868.1075 Argon gas analyzer. II  
  JEG -  Analyzer, Gas, Argon, Gaseous-Phase  
868.1150 Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer. II  
  CCC -  Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling  
868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer. II  
  CBZ -  Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling  
868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer. II  
  CCE -  Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling  
868.1400 Carbon dioxide gas analyzer. II  
  CCK -  Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase  
868.1430 Carbon monoxide gas analyzer. II  
  CCJ -  Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase  
868.1500 Enflurane gas analyzer. II  
  CBQ -  Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)  
  NHO -  Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)  
  NHP -  Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)  
  NHQ -  Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)  
868.1620 Halothane gas analyzer. II  
  CBS -  Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)  
868.1640 Helium gas analyzer. II  
  BSE -  Analyzer, Gas, Helium, Gaseous-Phase  
868.1670 Neon gas analyzer. II  
  JEF -  Analyzer, Gas, Neon, Gaseous-Phase  
868.1690 Nitrogen gas analyzer. II  
  CCI -  Analyzer, Gas, Nitrogen, Gaseous-Phase  
868.1700 Nitrous oxide gas analyzer. II  
  CBR -  Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)  
868.1720 Oxygen gas analyzer. II  
  CCL -  Analyzer, Gas, Oxygen, Gaseous-Phase  
868.1730 Oxygen uptake computer. II  
  BZL -  Computer, Oxygen-Uptake  
868.1750 Pressure plethysmograph. II  
  CCM -  Plethysmograph, Pressure  
868.1760 Volume plethysmograph. II  
  JEH -  Plethysmograph, Volume  
868.1780 Inspiratory airway pressure meter. II  
  BXR -  Meter, Airway Pressure (Inspiratory Force)  
868.1800 Rhinoanemometer. II  
  BXQ -  Rhinoanemometer (Measurement Of Nasal Decongestion)  
868.1840 Diagnostic spirometer. II  
  BZG -  Spirometer, Diagnostic  
868.1850 Monitoring spirometer. II  
  BZK -  Spirometer, Monitoring (W/Wo Alarm)  
868.1860 Peak-flow meter for spirometry. II  
  BZH -  Meter, Peak Flow, Spirometry  
868.1880 Pulmonary-function data calculator. II  
  BZC -  Calculator, Pulmonary Function Data  
868.1890 Predictive pulmonary-function value calculator. II  
  BTY -  Calculator, Predicted Values, Pulmonary Function  
  PDT -  Burn Resuscitation Decision Support Software  
868.1900 Diagnostic pulmonary-function interpretation calculator. II  
  BZM -  Calculator, Pulmonary Function Interpretor (Diagnostic)  
  PHZ -  Abnormal Breath Sound Device  
868.1920 Esophageal stethoscope with electrical conductors. II  
  BZT -  Stethoscope, Esophageal, With Electrical Conductors  
868.2025 Ultrasonic air embolism monitor. II  
  CBA -  Monitor, Air Embolism, Ultrasonic  
868.2375 Breathing frequency monitor. II  
  BZQ -  Monitor, Breathing Frequency  
  MNR -  Ventilatory Effort Recorder  
  PRK -  Device Indicating An Exhalation Event  
868.2385 Nitrogen dioxide analyzer. II  
  MRQ -  Analyzer, Nitrogen Dioxide  
868.2600 Airway pressure monitor. II  
  CAP -  Monitor, Airway Pressure (Includes Gauge And/Or Alarm)  
868.2775 Electrical peripheral nerve stimulator. II  
  BXM -  Stimulator, Nerve, Ac-Powered  
  BXN -  Stimulator, Nerve, Battery-Powered  
  KOI -  Stimulator, Nerve, Peripheral, Electric  
868.5090 Emergency airway needle. II  
  BWC -  Needle, Emergency Airway  
868.5120 Anesthesia conduction catheter. II  
  BSO -  Catheter, Conduction, Anesthetic  
  MAJ -  Catheter, Percutaneous, Intraspinal, Short Term  
868.5130 Anesthesia conduction filter. II  
  BSN -  Filter, Conduction, Anesthetic  
868.5140 Anesthesia conduction kit. II  
  CAZ -  Anesthesia Conduction Kit  
868.5150 Anesthesia conduction needle. II  
  BSP -  Needle, Conduction, Anesthetic (W/Wo Introducer)  
  MIA -  Needle, Spinal, Short Term  
  NMR -  Needle, Spinal, Short Term, Reprocessed  
  NNH -  Needle, Conduction, Anesthesia, Reprocessed  
868.5170 Laryngotracheal topical anesthesia applicator. II  
  CCT -  Applicator (Laryngo-Tracheal), Topical Anesthesia  
868.5260 Breathing circuit bacterial filter. II  
  CAH -  Filter, Bacterial, Breathing-Circuit  
868.5270 Breathing system heater. II  
  BZE -  Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer  
868.5330 Breathing gas mixer. II  
  BZR -  Mixer, Breathing Gases, Anesthesia Inhalation  
868.5430 Gas-scavenging apparatus. II  
  CBN -  Apparatus, Gas-Scavenging  
868.5440 Portable oxygen generator. II  
  CAW -  Generator, Oxygen, Portable  
868.5450 Respiratory gas humidifier. II  
  OBN -  Humidifier, Respiratory, Mask (Direct Patient Interface)  
868.5470 Hyperbaric chamber. II  
  CBF -  Chamber, Hyperbaric  
868.5655 Portable liquid oxygen unit. II  
  BYJ -  Unit, Liquid-Oxygen, Portable  
868.5665 Powered percussor. II  
  BYI -  Percussor, Powered-Electric  
868.5690 Incentive spirometer. II  
  BWF -  Spirometer, Therapeutic (Incentive)  
868.5730 Tracheal tube. II  
  LNZ -  Changer, Tube, Endotracheal  
868.5750 Inflatable tracheal tube cuff. II  
  BSK -  Cuff, Tracheal Tube, Inflatable  
868.5800 Tracheostomy tube and tube cuff. II  
  BTO -  Tube, Tracheostomy (W/Wo Connector)  
  JOH -  Tube Tracheostomy And Tube Cuff  
868.5870 Nonrebreathing valve. II  
  CBP -  Valve, Non-Rebreathing  
868.5880 Anesthetic vaporizer. II  
  CAD -  Vaporizer, Anesthesia, Non-Heated  
868.5895 Continuous ventilator. II  
  MOD -  Accessory To Continuous Ventilator (Respirator)  
868.5905 Noncontinuous ventilator (IPPB). II  
  NFB -  Conserver, Oxygen  
868.5915 Manual emergency ventilator. II  
  BTM -  Ventilator, Emergency, Manual (Resuscitator)  

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