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.
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Accessory, Assisted Reproduction, Exempt
Obstetrics/Gynecology
The Accessory, Assisted Reproduction (Exempt) is an obstetrics/gynecology device used as a supporting accessory in assisted reproduction procedures such as in vitro fertilization (IVF), providing ancillary support to primary reproductive technology instruments. Product code PUB is the Class II exempt counterpart of MQG, exempted from the 510(k) requirement under the 21st Century Cures Act, subject to the limitations in 21 CFR 884.9. Under regulation 21 CFR 884.6120, it is a Class II device subject to general and special controls. It falls under the Obstetrics/Gynecology medical specialty and is not flagged as an implant or life-sustaining device.
510(k) Clearances
1 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.