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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Orthosis, Pneumatic Structure, Rigid
Physical Medicine
A Rigid Pneumatic Structure Orthosis is an externally applied orthotic device used in Physical Medicine that incorporates an inflatable rigid structural element to provide support, immobilization, or positional correction to a limb or body segment. Per the regulatory record, a call for Pre-Market Approval (PMA) applications to be filed by December 26, 1996, was issued under 61 FR 50711. It is classified as FDA Class 3, the highest risk category requiring a Pre-Market Approval application demonstrating safety and effectiveness before marketing. The product code is IPO, regulated under 21 CFR 890.3610, within the Physical Medicine medical specialty.
No 510(k) clearances found for "IPO". 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.