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.
Tracheal Prosthesis With Cover Material Derived From Human Sources
Anesthesiology
A tracheal prosthesis with cover material derived from human sources is an expandable tubular metal implant covered with a human-sourced decellularized material, intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree; it may include a delivery system and does not include products intended to promote regeneration, impede inflammation, or release growth factors. It is classified as FDA Class II (510(k) required) under regulation 868.3721 in the Anesthesiology specialty, with product code SDB. The device is flagged as an implant, reflecting permanent placement, but does not support life-sustaining functions independently.
510(k) Clearances
1 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.