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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 July 22, 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.

Ear Nose & Throat

Section No. Regulation Name
Product Code-Device Name
874.1090 Auditory impedance tester.    
  ETY -  Tester, Auditory Impedance II
  NAS -  Tympanometer II
874.3302 Bone-conduction hearing aid.    
  LXB -  Hearing Aid, Bone Conduction II
874.3400 Tinnitus masker.    
  KLW -  Masker, Tinnitus II
874.4250 Ear, nose, and throat electric or pneumatic surgical drill.    
  ERL -  Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece II
874.4420 Ear, nose, and throat manual surgical instrument.    
  NLB -  Trocar, Tracheal, Laryngeal, Sinus, Reprocessed I
874.4490 Argon laser for otology, rhinology, and laryngology.    
  LMS -  Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology II
  LXR -  Laser, Microsurgical Argon, For Use In Otology II
874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.    
  LLO -  Laser, Neodymium:Yag, Pulmonary Surgery II
  EWG -  Laser, Ent Microsurgical Carbon-Dioxide II
874.4680 Bronchoscope (flexible or rigid) and accessories.    
  BST -  Curette, Biopsy, Bronchoscope (Non-Rigid) II
  BTG -  Brush, Biopsy, Bronchoscope (Non-Rigid) II
  BWH -  Forceps, Biopsy, Bronchoscope (Non-Rigid) II
  ENZ -  Telescope, Laryngeal-Bronchial II
  JEI -  Claw, Foreign Body, Bronchoscope (Non-Rigid) II
  JEJ -  Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating) II
874.4760 Nasopharyngoscope (flexible or rigid) and accessories.    
  EOB -  Nasopharyngoscope (Flexible Or Rigid) II