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.
On-Body Injector
General Hospital
The On-Body Injector is a Class 2 general hospital prescription device that adheres to the body and is intended to inject single or multiple doses of a medicinal product from a cartridge or reservoir in accordance with FDA-approved labeling, suitable for use by healthcare professionals or for patient self-injection, but not intended for continuous drug infusion. It requires 510(k) clearance and is regulated under 21 CFR 880.5860 within the General Hospital medical specialty. The product code is QLF. The device is not an implant and is not flagged as life-sustaining.
No 510(k) clearances found for "QLF". 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.