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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Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
General Hospital
The Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position (product code OMF) is a Class 2 implantable device regulated under 21 CFR 880.5970 in the General Hospital specialty (HO), cleared via 510(k). When used with a locator instrument, it is designed to aid in the real-time placement of central venous catheters by providing positional information during catheter insertion. The device is flagged as an implant due to its percutaneous, long-term implanted nature, and is not classified as life-sustaining.
510(k) Clearances
2 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.