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.
Orthosis, Cranial, Laser Scan
Neurology
The Orthosis, Cranial, Laser Scan (product code OAN) is a cranial remolding orthosis that uses laser scanning technology to create a customized fit, applying gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry and shape, indicated for infants aged 3 to 18 months with moderate to severe nonsynostotic positional plagiocephaly. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 882.5970 within the Neurology specialty. The device carries no implant or life-sustaining flags.
510(k) Clearances
23 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.