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.
Intrauterine Tamponade Balloon
Obstetrics/Gynecology
The Intrauterine Tamponade Balloon (product code OQY) is an obstetric device designed to provide temporary control or reduction of postpartum uterine bleeding. It is inserted into the uterus and inflated to apply pressure against the uterine walls to manage hemorrhage following childbirth. As an FDA Class 2 device under regulation 884.4530, it requires 510(k) premarket clearance and falls within the Obstetrics/Gynecology specialty. The device is not flagged as an implant and is not life-sustaining.
510(k) Clearances
10 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.