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.
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
General, Plastic Surgery
The Single Use Only Blood Lancet Without an Integral Sharps Injury Prevention Feature is a disposable lancet comprised of a single-use blade attached to a solid, non-reusable base, used to puncture the skin and obtain a drop of blood for in vitro diagnostic purposes. It is designed for single-patient, single-use application without a safety mechanism to prevent needlestick injury. Classified as FDA Class 2 under regulation 878.4850, it requires 510(k) clearance and falls under the General and Plastic Surgery specialty. The device is not an implant and not life-sustaining.
510(k) Clearances
15 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.