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.
Pelviscopy Kit
General, Plastic Surgery
The Pelviscopy Kit is a surgical convenience kit bundling instruments and supplies used to perform pelviscopy, a laparoscopic procedure for examining pelvic organs. It is classified as a Class 1 device under regulation 878.4800, subject to general controls, and per the FDA's May 1997 convenience kits guidance, it qualifies for enforcement discretion and does not require a 510(k) premarket notification if all guidance criteria are met. The product code is PYD, and it falls within the General, Plastic Surgery (SU) medical specialty. It is not an implant and is not life-sustaining.
No 510(k) clearances found for "PYD". Try a different K-number, product code, or device name.
What 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.