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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
General Hospital
The Tape and Bandage, Adhesive, Adjustable Closing Mechanism, OTC Use is a medical device consisting of a strip of fabric or plastic material coated on one side with an adhesive, used over-the-counter to cover and protect wounds, hold together skin edges of a wound, support an injured body part, or secure objects to the skin. It is classified as a Class 1 device under regulation 880.5240, subject to general controls only and exempt from 510(k) premarket notification. The product code is PYO, and it falls within the General Hospital (HO) medical specialty, reviewed by the Surgery panel. It is not an implant and is not life-sustaining.
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.