• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

List of Devices for Third Party Review

  • Print
  • Share
  • E-mail
-

Database updated: February 7, 2002

See Related 

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.


General Hospital

Help
Section No. Regulation Name
Product Code-Device Name
Class Pilot
Available
Guidance/Standard
880.2420 Electronic monitor for gravity flow infusion systems. II  
  FLN -  Monitor, Electric For Gravity Flow Infusion Systems   Pilot
    880.2460 Electrically powered spinal fluid pressure monitor. II  
      CAR -  Monitor, Spinal-Fluid Pressure, Electrically Powered   Pilot
      880.2500 Spinal fluid manometer. II  
        FMJ -  Manometer, Spinal-Fluid   Pilot
        880.2800 Sterilization process indicator. II  
          FRC -  Indicator, Biological Sterilization Process   Pilot
          JOJ -  Indicator, Physical/Chemical Sterilization Process   Pilot
          LRT -  Indicator, Sterilization   Pilot
          MRB -  Indicator, Biological, Liquid Chemical Sterilization Process   Pilot
            MTC -  Indicator, Chemical, Enzymatic, Sterilization Process   Pilot
          880.2910 Clinical electronic thermometer. II  
            FLL -  Thermometer, Electronic, Clinical    
          880.5025 I.V. container. II  
            KPE -  Container, I.V.   Pilot
            880.5045 Medical recirculating air cleaner. II  
              FRF -  Cleaner, Air, Medical Recirculating   Pilot
              880.5090 Liquid bandage. I  
                KMF -  Bandage, Liquid    
                  NEC -  Bandage, Liquid, Skin Protectant    
                  880.5130 Infant radiant warmer. II  
                    FMT -  Warmer, Infant Radiant   Pilot
                  880.5200 Intravascular catheter. II  
                    FOS -  Catheter, Umbilical Artery    
                    FOZ -  Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days    
                  880.5400 Neonatal incubator. II  
                    FMZ -  Incubator, Neonatal    
                  880.5410 Neonatal transport incubator. II  
                    FPL -  Incubator, Neonatal Transport    
                  880.5430 Nonelectrically powered fluid injector. II  
                    KZE -  Injector, Fluid, Non-Electrically Powered   Pilot
                  880.5440 Intravascular administration set. II  
                    BRZ -  Set, Blood Transfusion    
                    FMG -  Stopcock, I.V. Set    
                    FPA -  Set, Administration, Intravascular    
                    FPB -  Filter, Infusion Line    
                    FPK -  Tubing, Fluid Delivery    
                    LHI -  Set, I.V. Fluid Transfer    
                    MJF -  Check Valve, Retrograde Flow (In-Line)    
                  880.5450 Patient care reverse isolation chamber. II  
                    FRR -  Chamber, Reverse Isolation, Patient Care   Pilot
                      LGM -  Chamber, Patient Isolation   Pilot
                        LGN -  Chamber, Patient Transport Isolation   Pilot
                        880.5570 Hypodermic single lumen needle. II  
                          FMI -  Needle, Hypodermic, Single Lumen    
                          MMK -  Container, Sharps    
                        880.5580 Acupuncture needle. II  
                          MQX -  Needle, Acupuncture, Single Use   Pilot
                          880.5680 Pediatric position holder. I  
                            FRP -  Holder, Infant Position    
                            880.5700 Neonatal phototherapy unit. II  
                              LBI -  Unit, Neonatal Phototherapy   Pilot
                            880.5725 Infusion pump. II  
                              FRN -  Pump, Infusion    
                              LZF -  Pump, Infusion, Analytical Sampling    
                              LZH -  Pump, Infusion, Enteral    
                              MEA -  Pump, Infusion, Pca    
                              MEB -  Pump, Infusion, Elastomeric    
                              MHD -  Pump, Infusion, Gallstone Dissolution    
                              MRZ -  Accessories, Pump, Infusion    
                              MRH -  Pump, Infusion, Ophthalmic   Pilot
                            880.5780 Medical support stocking. II  
                              DWL -  Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)   Pilot
                              880.5860 Piston syringe. II  
                                FMF -  Syringe, Piston    
                              880.6100 Ethylene oxide gas aerator cabinet. II  
                                FLI -  Cabinet, Ethylene-Oxide Gas Aerator   Pilot
                                880.6250 Non-powdered patient examination glove. I  
                                  FMC -  Patient Examination Glove    
                                  LYY -  Latex Patient Examination Glove    
                                  LYZ -  Vinyl Patient Examination Glove    
                                  LZA -  Polymer Patient Examination Glove    
                                  LZB -  Finger Cot    
                                  LZC -  Patient Examination Glove, Specialty    
                                880.6375 Patient lubricant. I  
                                  KMJ -  Lubricant, Patient    
                                    MMS -  Lubricant, Vaginal, Patient    
                                    880.6500 Medical ultraviolet air purifier. II  
                                      FRA -  Purifier, Air, Ultraviolet, Medical   Pilot
                                        MKB -  Device, Germicidal, Ultraviolet   Pilot
                                        880.6710 Medical ultraviolet water purifier. II  
                                          KMG -  Purifier, Water, Ultraviolet, Medical   Pilot
                                          880.6740 Vacuum-powered body fluid suction apparatus. II  
                                            PAD -  Chest Drainage Kit    
                                          880.6760 Protective restraint. I  
                                            BRT -  Restraint, Patient, Conductive    
                                              FMQ -  Restraint, Protective    
                                              880.6850 Sterilization wrap. II  
                                                FRG -  Wrap, Sterilization   Pilot
                                                  KCT -  Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   Pilot
                                                880.6860 Ethylene oxide gas sterilizer. II  
                                                  FLF -  Sterilizer, Ethylene-Oxide Gas   Pilot
                                                  MLR -  Sterilizer, Chemical   Pilot
                                                  880.6870 Dry-heat sterilizer. II  
                                                    KMH -  Sterilizer, Dry Heat   Pilot
                                                  880.6880 Steam sterilizer. II  
                                                    FLE -  Sterilizer, Steam    
                                                  880.6885 Liquid chemical sterilants/high level disinfectants. II  
                                                    LFE -  Solution, Cold Sterilizing   Pilot
                                                      MED -  Sterilant, Medical Devices    
                                                    880.6920 Syringe needle introducer. II  
                                                      KZH -  Introducer, Syringe Needle   Pilot

                                                    -
                                                    -