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.
Multiple Use Blood Lancet For Single Patient Use Only
General, Plastic Surgery
The Multiple Use Blood Lancet for Single Patient Use Only is a blood sampling device consisting of a single-use blade on a solid, reusable base, intended to puncture the skin to obtain a blood drop for diagnostic testing, with the base designed for repeated use by a single patient only. It differs from purely single-use lancets in that the base unit can be used across multiple lancing events for the same patient. Classified as FDA Class 2 under regulation 878.4850, it requires 510(k) clearance in the General and Plastic Surgery specialty. The device is not an implant and not life-sustaining.
510(k) Clearances
23 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.