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.
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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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Non-Surgical Gown
General, Plastic Surgery
The Non-Surgical Gown (product code OEA) is a general hospital protective garment intended to protect healthcare patients and personnel from the transfer of microorganisms, body fluids, and particulate material in non-surgical settings such as isolation precautions or general patient care. It differs from surgical gowns in that it is not designed to the higher barrier requirements of the sterile field. This device is FDA Class 1 under regulation 878.4040 in the General, Plastic Surgery specialty, subject only to general controls, and cleared through the De Novo pathway (submission type 4). It is not GMP-exempt and carries no implant or life-sustaining flags.
No 510(k) clearances found for "OEA". Try a different K-number, product code, or device name.
What 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.