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.
Needle, Isotope, Reprocessed
Radiology
The isotope needle (reprocessed) is a radiology device used to deliver or position radioactive isotopes for diagnostic or therapeutic nuclear medicine procedures. It is classified as FDA Class 2 under regulation 892.5730 in the Radiology specialty, requiring 510(k) premarket notification. As a reprocessed device under product code NMP, reprocessing validation data must be included in the 510(k) submission. This device is not eligible for third-party review.
No 510(k) clearances found for "NMP". 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.