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.
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Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
Ear, Nose, Throat
Laser, Microsurgical Argon, for Uses Other Than Otology, Including Laryngology and General Use in Otolaryngology is an argon laser system used in microsurgical procedures of the ear, nose, and throat, specifically for applications outside of the inner ear such as laryngeal surgery, treatment of vascular lesions, or other precision procedures in the head and neck region. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LMS, regulated under 21 CFR 874.4490, within the Ear, Nose, and Throat medical specialty. This device is eligible for third-party 510(k) review.
510(k) Clearances
2 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.