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.
Laryngoscope Kit
Anesthesiology
The Laryngoscope Kit is a convenience kit providing a laryngoscope and associated accessories used to visualize the larynx for intubation or airway assessment in anesthesia and emergency settings. It is classified as FDA Class 1 under regulation 21 CFR 868.5540 within the Anesthesiology medical specialty, the lowest risk tier subject to general controls only, and falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance without requiring a 510(k) submission. The product code is OGH. It is not flagged as an implant or life-sustaining device.
No 510(k) clearances found for "OGH". 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.