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.
Agents, Embolic, For Treatment Of Uterine Fibroids
Cardiovascular
Embolic Agents for Treatment of Uterine Fibroids are small particles or microspheres delivered via catheter into the uterine arteries to block blood flow to fibroid tumors, causing them to shrink in a procedure known as uterine fibroid embolization (UFE). These agents are implanted in the vasculature and remain in place. Classified as FDA Class 2, they require 510(k) premarket clearance under regulation 870.3300 (Cardiovascular specialty, reviewed by the Obstetrics/Gynecology panel). This device carries the implant flag.
510(k) Clearances
8 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.