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.
Maggots, Medical
Unknown
Medical maggots (Phaenicia sericata blow fly larvae) are harvested and provided in a disinfected form for use in debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and traumatic or post-surgical wounds. This product is classified as unclassified (FDA unclassified) under product code NQK, with regulatory oversight being transferred from the Center for Devices and Radiological Health (CDRH) to the Center for Biologics Evaluation and Research (CBER) per Federal Register Notice 89 FR 106521. It is not an implant or life-sustaining device and has no applicable regulation number.
510(k) Clearances
6 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.