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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Mercy Tape 2d And 3d Models
General, Plastic Surgery
The Mercy TAPE 2D and 3D Models are clinical measurement tools intended for use by healthcare professionals to estimate the body weight of pediatric patients between 2 months and 16 years of age using linear measurements from anatomical landmarks, including humeral length or half-humeral length and mid-upper arm circumference. They are FDA Class 1 devices regulated under 21 CFR 878.4800, subject to general controls, within the General and Plastic Surgery (SU) specialty. The product code is PIR, and the device is eligible for third-party review. These devices are not implants and are not life-sustaining.
510(k) Clearances
2 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.