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 Reprocessed Ultrasonic Surgical Instruments
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The Single-Use Reprocessed Ultrasonic Surgical Instruments are reprocessed versions of single-use ultrasonic surgical devices used either for fragmentation, emulsification, and aspiration of soft and hard tissue or for vessel ligation during surgical procedures; reprocessing validation data must be included in the submission. These devices are unclassified (device class "U") with an unclassified reason code of 1, subject to FDA's 510(k) pathway, under product code NLQ in the General and Plastic Surgery review panel (no regulation number assigned). The devices carry no implant or life-sustaining flags.
510(k) Clearances
26 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.