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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
System, Assisted Reproduction Laser
Obstetrics/Gynecology
The Assisted Reproduction Laser System is an obstetrics/gynecology device that uses laser energy to perform zona pellucida drilling or thinning (assisted hatching) on embryos in selected IVF patients who have poor prognosis for successful pregnancy, such as those of advanced maternal age, prior failed IVF cycles, or with cryopreserved or morphologically abnormal embryos. Classified as FDA Class 2 under 21 CFR 884.6200, it requires 510(k) premarket notification. The product code is MRX.
510(k) Clearances
11 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.