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.
Catheter, Percutaneous, Intraspinal, Short Term
Anesthesiology
The short-term percutaneous intraspinal catheter is an anesthesiology device inserted through the skin into the spinal canal to deliver anesthetic or analgesic agents for pain management. It is classified as FDA Class II under 21 CFR 868.5120, requiring 510(k) premarket clearance, and is eligible for third-party review as indicated by its third-party flag. The product code is MAJ and it is reviewed under the Hematology/Oncology panel despite its Anesthesiology specialty designation. Full GMP compliance is required and the device is not implanted long-term.
510(k) Clearances
6 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.