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.
Allergen And Vaccine Delivery Needles
General Hospital
Allergen and vaccine delivery needles are devices intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests (skin prick tests or intradermal allergy tests), enabling standardized allergen delivery for accurate diagnosis of allergic conditions. They are classified as FDA Class II (510(k) required) under regulation 880.5570 in the General Hospital specialty, with product code SCL; they are eligible for third-party review. The device is not an implant and does not support life-sustaining functions.
510(k) Clearances
24 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.