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.
Tubing And Tubing/Filter Fits
Obstetrics/Gynecology
The Hysteroscopy Tubing and Tubing/Filter Fits are devices used during hysteroscopy procedures to distend the uterine cavity by filling it with liquid or gas, facilitating visualization with a hysteroscope. These accessories are essential components supporting uterine distension media delivery during diagnostic and operative hysteroscopy. It is an FDA Class 1 device regulated under 21 CFR 884.1700 in the Obstetrics/Gynecology specialty, with product code NVT, and is exempt from premarket notification under submission type 4. It does not carry implant or life-sustaining support designations.
No 510(k) clearances found for "NVT". 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.