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.
Prostate Seeding Kit
Radiology
The Prostate Seeding Kit is a convenience kit containing components used to implant radioactive seeds into the prostate gland as part of brachytherapy for prostate cancer, a localized radiation treatment. Classified as FDA Class 2 under regulation 21 CFR 892.5730 within the Radiology medical specialty, it is exempt from 510(k) premarket notification per FDA Federal Register (82 FR 31976) and also subject to enforcement discretion under the 1997 Convenience Kits guidance. The product code is OIN. It is not flagged as an implant or life-sustaining device.
No 510(k) clearances found for "OIN". 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.