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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 June 24, 2024

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.


General Hospital

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Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
880.2420 Electronic monitor for gravity flow infusion systems.    
  FLN -  Monitor, Electric For Gravity Flow Infusion Systems II
880.2460 Electrically powered spinal fluid pressure monitor.    
  CAR -  Monitor, Spinal-Fluid Pressure, Electrically Powered II
880.2500 Spinal fluid manometer.    
  FMJ -  Manometer, Spinal-Fluid II
880.2800 Sterilization process indicator.    
  FRC -  Indicator, Biological Sterilization Process II
  JOJ -  Indicator, Physical/Chemical Sterilization Process II
  LRT -  Indicator, Sterilization II
  MRB -  Indicator, Biological, Liquid Chemical Sterilization Process II
  MTC -  Indicator, Chemical, Enzymatic, Sterilization Process II
  OCI -  Indicator, Physical/Chemical, Storage Temperature II
880.2910 Clinical electronic thermometer.    
  FLL -  Thermometer, Electronic, Clinical II
880.5025 I.V. container.    
  KPE -  Container, I.V. II
880.5045 Medical recirculating air cleaner.    
  FRF -  Cleaner, Air, Medical Recirculating II
880.5090 Liquid bandage.    
  KMF -  Bandage, Liquid I
880.5130 Infant radiant warmer.    
  FMT -  Warmer, Infant Radiant II
  ONM -  Radiant Infant Warmer Cabinet II
880.5200 Intravascular catheter.    
  FOS -  Catheter, Umbilical Artery II
  FOZ -  Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days II
880.5240 Medical adhesive tape and adhesive bandage.    
  FPX -  Strip, Adhesive, Closure, Skin I
880.5400 Neonatal incubator.    
  FMZ -  Incubator, Neonatal II
880.5410 Neonatal transport incubator.    
  FPL -  Incubator, Neonatal Transport II
880.5440 Intravascular administration set.    
  BRZ -  Set, Blood Transfusion II
  FMG -  Stopcock, I.V. Set II
  FPA -  Set, Administration, Intravascular II
  FPB -  Filter, Infusion Line II
  FPK -  Tubing, Fluid Delivery II
  LHI -  Set, I.V. Fluid Transfer II
  MJF -  Check Valve, Retrograde Flow (In-Line) II
880.5450 Patient care reverse isolation chamber.    
  FRR -  Chamber, Reverse Isolation, Patient Care II
  LGM -  Chamber, Patient Isolation II
  LGN -  Chamber, Patient Transport Isolation II
880.5570 Hypodermic single lumen needle.    
  FMI -  Needle, Hypodermic, Single Lumen II
  MMK -  Container, Sharps II
  NKK -  Needle, Hypodermic, Single Lumen, Reprocessed II
  PVZ -  Non-Stainless Steel Needle II
880.5580 Acupuncture needle.    
  NRW -  Stimulator, Intramuscular, Automatic II
880.5680 Pediatric position holder.    
  FRP -  Holder, Infant Position I
  OUW -  Infant Positioner, Rx, Use In Highly Monitored Setting I
880.5700 Neonatal phototherapy unit.    
  LBI -  Unit, Neonatal Phototherapy II
  PDH -  Blanket, Neonatal Phototherapy II
880.5860 Piston syringe.    
  FMF -  Syringe, Piston II
  MEG -  Syringe, Antistick II
  QBL -  Piston Syringe Lever II
880.6100 Ethylene oxide gas aerator cabinet.    
  FLI -  Cabinet, Ethylene-Oxide Gas Aerator II
880.6250 Non-powdered patient examination glove.    
  FMC -  Patient Examination Glove I
  LYY -  Latex Patient Examination Glove I
  LYZ -  Vinyl Patient Examination Glove I
  LZA -  Polymer Patient Examination Glove I
  LZC -  Medical Glove, Specialty I
  OIG -  Powder-Free Guayle Rubber Examination Glove I
  OPC -  Powder-Free Polychloroprene Patient Examination Glove I
  OPH -  Radiation Attenuating Medical Glove I
  OPJ -  Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs I
880.6375 Patient lubricant.    
  ONK -  Oral Lubricant I
  MMS -  Lubricant, Vaginal, Patient I
880.6500 Medical ultraviolet air purifier.    
  FRA -  Purifier, Air, Ultraviolet, Medical II
  MKB -  Device, Germicidal, Ultraviolet II
880.6600 Ultraviolet (UV) radiation chamber disinfection device.    
  OSZ -  Antimicrobial Keyboard II
880.6850 Sterilization wrap.    
  FRG -  Wrap, Sterilization II
  KCT -  Sterilization Wrap Containers, Trays, Cassettes & Other Accessories II
880.6860 Ethylene oxide gas sterilizer.    
  MLR -  Sterilizer, Chemical II
880.6870 Dry-heat sterilizer.    
  KMH -  Sterilizer, Dry Heat II
880.6880 Steam sterilizer.    
  FLE -  Sterilizer, Steam II
  PEC -  Sterilizer Automated Loading System II
880.6885 Liquid chemical sterilants/high level disinfectants.    
  LFE -  Solution, Cold Sterilizing II
  MED -  Sterilant, Medical Devices II
880.6992 Medical washer-disinfector.    
  MDZ -  Cleaners, Medical Devices II

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