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.
Enteral Specific Transition Connectors
Gastroenterology, Urology
Enteral Specific Transition Connectors are medical devices that facilitate connections between AAMI/CN3(PS):2014 compliant connectors and non-ISO 80369-1 compliant legacy enteral connectors, enabling safe enteral feeding during the transition to standardized connector systems. They are FDA Class 2 devices regulated under 21 CFR 876.5980, requiring 510(k) premarket notification, within the Gastroenterology and Urology (GU) specialty. The product code is PIO. These devices are not implants and are not life-sustaining.
510(k) Clearances
9 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.