510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Ear, Nose, Throat
ENT Synthetic Polyamide Polymer (Mesh or Foil Material) is an implantable material used in ear, nose, and throat surgery, fabricated from synthetic polyamide polymer in mesh or foil form, to reconstruct or reinforce structural defects in the head and neck region, including tympanic membrane repair or middle ear reconstruction. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHJ, regulated under 21 CFR 874.3620, within the Ear, Nose, Throat medical specialty. This device is an implant.
510(k) Clearances
33 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.