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.
Biological Sterilization Indicator With Indirect Growth Detection
General Hospital
The Biological Sterilization Indicator with Indirect Growth Detection is a device placed with products during sterilization processes to monitor sterilization adequacy, using an indirect method (other than direct detection of microbial growth or growth products) to detect surviving microorganisms and confirm whether sterilization conditions were met. Classified as FDA Class 2 under regulation 880.2806, it requires 510(k) clearance in the General Hospital specialty. The device is not an implant and not life-sustaining.
510(k) Clearances
3 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.