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.
Curette, Uterine
Obstetrics/Gynecology
The Uterine Curette is a manual gynecological surgical instrument with a spoon-shaped or loop-shaped end used to scrape or remove tissue from the inner lining of the uterus for diagnostic or therapeutic purposes, such as in dilation and curettage (D&C) procedures. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HCY under regulation 21 CFR 884.4530 in the Obstetrics/Gynecology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
510(k) Clearances
11 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.