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.
Lacrimal Stents And Intubation Sets
Unknown
Lacrimal Stents and Intubation Sets (product code OKS) are unclassified devices reviewed by the Ophthalmic (OP) panel that have undergone 510(k) review but remain without a final classification. They are intended to repair the lacrimal drainage system and are indicated for the treatment of epiphora in infants and adults, canalicular pathologies such as stenosis, obstruction or laceration, conditions requiring dacryocystorhinostomy, or nasolacrimal duct imperforation in infants. Notably, the device carries an implant flag, indicating it is intended to be placed within or on the body.
510(k) Clearances
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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.