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.
Non-Stainless Steel Needle
General Hospital
The Non-Stainless Steel Needle is a general hospital device consisting of a hypodermic needle made from materials other than stainless steel, intended to inject medication and aspirate fluid below the skin surface, and specifically designed for use with ultrasound guidance to improve needle visualization during procedures. It is classified as FDA Class II under regulation 21 CFR 880.5570, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PVZ, falls under the General Hospital medical specialty, and is eligible for third-party review. It is not flagged as an implant or life-sustaining device.
510(k) Clearances
1 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.