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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: February 7, 2002

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This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five 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 indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


Anesthesiology

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Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
868.1040 POWERED ALGESIMETER II  
  BSI -  Algesimeter, Powered   Pilot  
868.1075 ARGON GAS ANALYZER II  
  JEG -  Analyzer, Gas, Argon, Gaseous-Phase   Pilot  
868.1150 INDWELLING BLOOD CARBON DIOXIDE PARTIAL PRESSURE (PCO2) ANALYZER II  
  CCC -  Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling   Pilot  
868.1170 INDWELLING BLOOD HYDROGEN ION CONCENTRATION (PH) ANALYZER II  
  CBZ -  Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling   Pilot  
868.1200 INDWELLING BLOOD OXYGEN PARTIAL PRESSURE (P02) ANALYZER II  
  CCE -  Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling   Pilot  
868.1400 CARBON-DIOXIDE GAS ANALYZER II  
  CCK -  Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   Pilot  
868.1430 CARBON-MONOXIDE GAS ANALYZER II  
  CCJ -  Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase   Pilot  
868.1500 ENFLURANE GAS ANALYZER II  
  CBQ -  Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)   Pilot  
  NHO -  Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)   Pilot  
  NHP -  Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)   Pilot  
  NHQ -  Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)   Pilot  
868.1620 HALOTHANE GAS ANALYZER II  
  CBS -  Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)   Pilot  
868.1640 HELIUM GAS ANALYZER II  
  BSE -  Analyzer, Gas, Helium, Gaseous-Phase   Pilot  
868.1670 NEON GAS ANALYZER II  
  JEF -  Analyzer, Gas, Neon, Gaseous-Phase   Pilot  
868.1690 NITROGEN GAS ANALYZER II  
  CCI -  Analyzer, Gas, Nitrogen, Gaseous-Phase   Pilot  
868.1700 NITROUS-OXIDE GAS ANALYZER II  
  CBR -  Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)   Pilot  
868.1720 OXYGEN GAS ANALYZER II  
  CCL -  Analyzer, Gas, Oxygen, Gaseous-Phase   Pilot  
868.1730 OXYGEN-UPTAKE COMPUTER II  
  BZL -  Computer, Oxygen-Uptake   Pilot  
868.1750 PRESSURE PLETHYSMOGRAPH II  
  CCM -  Plethysmograph, Pressure   Pilot  
868.1760 VOLUME PLETHYSMOGRAPH II  
  JEH -  Plethysmograph, Volume   Pilot  
868.1780 INSPIRATORY AIRWAY PRESSURE METER II  
  BXR -  Meter, Airway Pressure (Inspiratory Force)   Pilot  
868.1800 RHINOANEMOMETER II  
  BXQ -  Rhinoanemometer (Measurement Of Nasal Decongestion)   Pilot  
868.1840 DIAGNOSTIC SPIROMETER II  
  BZG -  Spirometer, Diagnostic   Pilot  
868.1850 MONITORING SPIROMETER II  
  BZK -  Spirometer, Monitoring (W/Wo Alarm)   Pilot  
868.1860 PEAK FLOW METER FOR SPIROMETRY II  
  BZH -  Meter, Peak Flow, Spirometry   Pilot  
868.1880 PULMONARY FUNCTION DATA CALCULATOR II  
  BZC -  Calculator, Pulmonary Function Data   Pilot  
868.1890 PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR II  
  BTY -  Calculator, Predicted Values, Pulmonary Function   Pilot  
  NDC -  Calculator, Drug Dose   Pilot  
868.1900 DIAGNOSTIC PULMONARY FUNCTION INTERPRETATION CALCULATOR II  
  BZM -  Calculator, Pulmonary Function Interpretator (Diagnostic)   Pilot  
868.1920 ESOPYAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS II  
  BZT -  Stethoscope, Esophageal, With Electrical Conductors   Pilot  
868.2025 ULTRASONIC AIR EMBOLISM MONITOR II  
  CBA -  Monitor, Air Embolism, Ultrasonic   Pilot  
868.2375 BREATHING FREQUENCY MONITOR II  
 
  BZQ -  Monitor, Breathing Frequency      
  MNR -  Ventilatory Effort Recorder   Pilot  
868.2385 NITROGEN DIOXIDE ANALYZER II  
  MRQ -  Analyzer, Nitrogen Dioxide   Pilot  
868.2500 CUTANEOUS OXYGEN MONITOR II  
  KLK -  Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia   Pilot  
868.2550 PNEUMOTACHOMETER II  
  JAX -  Pneumotachometer   Pilot  
868.2600 AIRWAY PRESSURE MONITOR II  
  CAP -  Monitor, Airway Pressure (Includes Gauge And/Or Alarm)   Pilot  
868.2775 ELECTRICAL PERIPHERAL NERVE STIMULATOR II  
  BXM -  Stimulator, Nerve, Ac-Powered   Pilot  
  BXN -  Stimulator, Nerve, Battery-Powered   Pilot  
  KOI -  Stimulator, Nerve, Peripheral, Electric   Pilot  
868.5090 EMERGENCY AIRWAY NEEDLE II  
  BWC -  Needle, Emergency Airway   Pilot  
868.5120 ANESTHESIA CONDUCTION CATHETER II  
  BSO -  Catheter, Conduction, Anesthetic   Pilot  
868.5130 ANESTHESIA CONDUCTION FILTER II  
  BSN -  Filter, Conduction, Anesthetic   Pilot  
868.5140 ANESTHESIA CONDUCTION KIT II  
  CAZ -  Anesthesia Conduction Kit   Pilot  
868.5150 ANESTHESIA CONDUCTION NEEDLE II  
  BSP -  Needle, Conduction, Anesthetic (W/Wo Introducer)   Pilot  
  MIA -  Needle, Spinal, Short Term   Pilot  
868.5160 GAS MACHINE FOR ANESTHESIA II  
  BSZ -  Gas-Machine, Anesthesia   Pilot  
868.5170 LARYNGO-TRACHEAL TOPICAL ANESTHESIA APPLICATOR II  
  CCT -  Applicator (Laryngo-Tracheal), Topical Anesthesia   Pilot  
868.5180 ROCKING BED II  
  CCO -  Bed, Rocking, Breathing Assist   Pilot  
868.5250 BREATHING CIRCUIT CIRCULATOR II  
  CAG -  Circulator, Breathing-Circuit   Pilot  
868.5260 BREATHING CIRCUIT BACTERIAL FILTER II  
  CAH -  Filter, Bacterial, Breathing-Circuit   Pilot  
868.5270 BREATHING SYSTEM HEATER II  
  BZE -  Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer   Pilot  
868.5330 BREATHING GAS MIXER II  
  BZR -  Mixer, Breathing Gases, Anesthesia Inhalation   Pilot  
868.5430 GAS-SCAVENGING APPARATUS II  
  CBN -  Apparatus, Gas-Scavenging   Pilot  
868.5440 PORTABLE OXYGEN GENERATOR II  
 
  CAW -  Generator, Oxygen, Portable      
868.5450 RESPIRATORY GAS HUMIDIFIER II  
  BTT -  Humidifier, Respiratory Gas, (Direct Patient Interface)   Pilot  
868.5470 HYPERBARIC CHAMBER II  
 
  CBF -  Chamber, Hyperbaric      
868.5630 NEBULIZER II  
  CAF -  Nebulizer (Direct Patient Interface)      
868.5655 PORTABLE LIQUID OXYGEN UNIT II  
  BYJ -  Unit, Liquid-Oxygen, Portable   Pilot  
868.5665 POWERED PERCUSSOR II  
  BYI -  Percussor, Powered-Electric   Pilot  
868.5690 INCENTIVE SPIROMETER II  
  BWF -  Spirometer, Therapeutic (Incentive)   Pilot  
868.5710 ELECTRICALLY POWERED OXYGEN TENT II  
  BYK -  Tent, Oxygen, Electrically Powered   Pilot  
  FNC -  Tent, Pediatric Aerosol   Pilot  
868.5730 TRACHEAL TUBE II  
  LNZ -  Changer, Tube, Endotracheal   Pilot  
868.5750 INFLATABLE TRACHEAL TUBE CUFF II  
  BSK -  Cuff, Tracheal Tube, Inflatable   Pilot  
868.5800 TRACHEOSTOMY TUBE AND TUBE CUFF II  
  BTO -  Tube, Tracheostomy (W/Wo Connector)   Pilot  
  JOH -  Tube Tracheostomy And Tube Cuff   Pilot  
  NXA -  Kit, Tracheotomy Care   Pilot  
868.5870 NONREBREATHING VALVE II  
  CBP -  Valve, Non-Rebreathing   Pilot  
868.5880 ANESTHETIC VAPORIZER II  
  CAD -  Vaporizer, Anesthesia, Non-Heated   Pilot  
868.5895 CONTINUOUS VENTILATOR II  
  MOD -  Accessory To Continuous Ventilator (Respirator)   Pilot  
868.5905 NONCONTINUOUS VENTILATOR II  
  HTML Guidance file for NONCONTINUOUS VENTILATOR (21CFR868.5905)
  HTML Guidance file for NONCONTINUOUS VENTILATOR (21CFR868.5905)
  NFB -  Conserver, Oxygen      
868.5915 MANUAL EMERGENCY VENTILATOR II  
  BTM -  Ventilator, Emergency, Manual (Resuscitator)   Pilot  
868.5925 POWERED EMERGENCY VENTILATOR II  
  BTL -  Ventilator, Emergency, Powered (Resuscitator)   Pilot  
868.5935 EXTERNAL NEGATIVE PRESSURE VENTILATOR II  
  BYT -  Ventilator, External Body, Negative Pressure, Adult (Cuirass)   Pilot  
868.5965 POSITIVE END EXPIRATORY PRESSURE ATTACHMENT II  
  BYE -  Attachment, Breathing, Positive End Expiratory Pressure   Pilot  
868.6250 PORTABLE AIR COMPRESSOR II  
  BTI -  Compressor, Air, Portable   Pilot  

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