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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Clinical Electronic Thermometer
General Hospital
A clinical electronic thermometer is a General Hospital device used to intermittently measure a patient's body temperature via a transducer coupled with electronic signal amplification, conditioning, and display; this product code represents the Class II exempt category that does not require premarket notification (510(k)) provided it does not exceed the general and specific limitations of exemption. It is classified as FDA Class II under regulation 880.2910 in the General Hospital specialty, with product code SDV, and was exempted under procedures established by section 510(m) of the FD&C Act as described in 90 FR 25889. The device is not an implant and does not support life-sustaining functions.
No 510(k) clearances found for "SDV". 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.