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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Artificial Chordae Tendineae Surgical Replacement System
Cardiovascular
An artificial chordae tendineae surgical replacement system is a standalone prescription implant device consisting of nonabsorbable suture-based implants and suture placement devices used via open surgical approach under direct visualization to replace mitral or tricuspid chordae tendineae in patients with atrioventricular valve insufficiency; it includes clips or fasteners to secure the suture but is not intended for transcatheter or percutaneous access. It is classified as FDA Class II (510(k) required) under regulation 870.3490 in the Cardiovascular specialty, with product code SBK. The device is flagged as both an implant and life-sustaining, reflecting its critical cardiac function.
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.