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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.


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. II  
  FLN -  Monitor, Electric For Gravity Flow Infusion Systems  
880.2460 Electrically powered spinal fluid pressure monitor. II  
  CAR -  Monitor, Spinal-Fluid Pressure, Electrically Powered  
880.2500 Spinal fluid manometer. II  
  FMJ -  Manometer, Spinal-Fluid  
880.2800 Sterilization process indicator. II  
  FRC -  Indicator, Biological Sterilization Process  
  JOJ -  Indicator, Physical/Chemical Sterilization Process  
  LRT -  Indicator, Sterilization  
  MRB -  Indicator, Biological, Liquid Chemical Sterilization Process  
  MTC -  Indicator, Chemical, Enzymatic, Sterilization Process  
  OCI -  Indicator, Physical/Chemical, Storage Temperature  
880.2910 Clinical electronic thermometer. II  
  FLL -  Thermometer, Electronic, Clinical  
880.5025 I.V. container. II  
  KPE -  Container, I.V.  
880.5045 Medical recirculating air cleaner. II  
  FRF -  Cleaner, Air, Medical Recirculating  
880.5090 Liquid bandage. I  
  KMF -  Bandage, Liquid  
880.5130 Infant radiant warmer. II  
  FMT -  Warmer, Infant Radiant  
  ONM -  Radiant Infant Warmer Cabinet  
880.5200 Intravascular catheter. II  
  FOS -  Catheter, Umbilical Artery  
  FOZ -  Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days  
880.5240 Medical adhesive tape and adhesive bandage. I  
  FPX -  Strip, Adhesive, Closure, Skin  
880.5400 Neonatal incubator. II  
  FMZ -  Incubator, Neonatal  
880.5410 Neonatal transport incubator. II  
  FPL -  Incubator, Neonatal Transport  
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  
  LGM -  Chamber, Patient Isolation  
  LGN -  Chamber, Patient Transport Isolation  
880.5570 Hypodermic single lumen needle. II  
  FMI -  Needle, Hypodermic, Single Lumen  
  MMK -  Container, Sharps  
  NKK -  Needle, Hypodermic, Single Lumen, Reprocessed  
  PVZ -  Non-Stainless Steel Needle  
880.5580 Acupuncture needle. II  
  NRW -  Stimulator, Intramuscular, Automatic  
880.5680 Pediatric position holder. I  
  FRP -  Holder, Infant Position  
  OUW -  Infant Positioner, Rx, Use In Highly Monitored Setting  
880.5700 Neonatal phototherapy unit. II  
  LBI -  Unit, Neonatal Phototherapy  
  PDH -  Blanket, Neonatal Phototherapy  
880.5860 Piston syringe. II  
  FMF -  Syringe, Piston  
  MEG -  Syringe, Antistick  
  QBL -  Piston Syringe Lever  
880.6100 Ethylene oxide gas aerator cabinet. II  
  FLI -  Cabinet, Ethylene-Oxide Gas Aerator  
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  
  LZC -  Patient Examination Glove, Specialty  
  OIG -  Powder-Free Guayle Rubber Examination Glove  
  OPC -  Powder-Free Polychloroprene Patient Examination Glove  
  OPH -  Radiation Attenuating Medical Glove  
  OPJ -  Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs  
880.6375 Patient lubricant. I  
  ONK -  Oral Lubricant  
  MMS -  Lubricant, Vaginal, Patient  
880.6500 Medical ultraviolet air purifier. II  
  FRA -  Purifier, Air, Ultraviolet, Medical  
  MKB -  Device, Germicidal, Ultraviolet  
880.6600 Ultraviolet (UV) radiation chamber disinfection device. II  
  OSZ -  Antimicrobial Keyboard  
880.6850 Sterilization wrap. II  
  FRG -  Wrap, Sterilization  
  KCT -  Sterilization Wrap Containers, Trays, Cassettes & Other Accessories  
880.6860 Ethylene oxide gas sterilizer. II  
  MLR -  Sterilizer, Chemical  
880.6870 Dry-heat sterilizer. II  
  KMH -  Sterilizer, Dry Heat  
880.6880 Steam sterilizer. II  
  FLE -  Sterilizer, Steam  
  PEC -  Sterilizer Automated Loading System  
880.6885 Liquid chemical sterilants/high level disinfectants. II  
  LFE -  Solution, Cold Sterilizing  
  MED -  Sterilant, Medical Devices  
880.6992 Medical washer-disinfector. II  
  MDZ -  Cleaners, Medical Devices  

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