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.
General Wellness Product
Unknown
The General Wellness Product encompasses devices that promote general health and well-being without making specific medical claims, as defined by FDA's General Wellness Policy, and this product code is designated specifically for import classification purposes. It is classified as unclassified (device class N) with no regulation number assigned, and is GMP exempt per its unclassified reason code. The product code is PWC, reviewed under the General Hospital panel, and it is not flagged as an implant or life-sustaining device. As a general wellness product it is not subject to the same marketing controls as FDA-regulated medical devices.
No 510(k) clearances found for "PWC". 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.