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.
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Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Autonomous Extracorporeal Blood Leak Detector/Alarm
Gastroenterology, Urology
The Autonomous Extracorporeal Blood Leak Detector/Alarm (product code ODX) is a gastroenterology/urology device used in hemodialysis settings to detect the presence of blood leaking from extracorporeal connections or needle sites, alerting the user or attending staff via colorimetric, chemical, or light modulation changes caused by exposure to leaking blood. Early detection of blood leaks helps prevent life-threatening blood loss in dialysis patients. This device is FDA Class 2 under regulation 876.5820 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
510(k) Clearances
4 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.