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.
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Obstetrics/Gynecology
The Lubricant, Personal, Gamete, Fertilization, and Embryo Compatible is an obstetrics/gynecology device for penile and/or vaginal application intended to moisturize and lubricate while being compatible with gametes, fertilization processes, and embryos, making it suitable for use by couples undergoing fertility treatments. It falls under the Obstetrics/Gynecology medical specialty and is classified as a Class 2 device under regulation 884.5300, requiring 510(k) premarket notification. Standard personal lubricants can be harmful to sperm and embryos, making this specialized compatibility an important regulatory distinction. It is not an implant and is not life-sustaining.
510(k) Clearances
10 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.