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.
Analyzer, Body Composition, Exempt
Cardiovascular
The Analyzer, Body Composition (Exempt) is a device used to measure and analyze body composition parameters such as fat mass, lean mass, and body water, typically through bioelectrical impedance analysis or similar techniques, to aid in nutritional assessment and clinical management. Product code PUH is the Class II exempt counterpart of MNW, exempted from the 510(k) requirement under the 21st Century Cures Act, subject to the limitations in 21 CFR 870.9. Under regulation 21 CFR 870.2770, it is a Class II device subject to general and special controls. It falls under the Cardiovascular medical specialty and is not flagged as an implant or life-sustaining device.
No 510(k) clearances found for "PUH". 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.