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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Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
General, Plastic Surgery
The Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Exempt) is a general/plastic surgery device consisting of sterile stainless steel suture material in both monofilament and multifilament configurations, used to close wounds and approximate tissue during surgical procedures where long-term or permanent closure is required. Product code PTX is the Class II exempt counterpart of GAQ, exempted from the 510(k) requirement under the 21st Century Cures Act, subject to the limitations in 21 CFR 878.9. Under regulation 21 CFR 878.4495, it is a Class II device subject to general and special controls. It is flagged as an implant, reflecting its use as a permanent or long-term tissue approximation device.
No 510(k) clearances found for "PTX". 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.