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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Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia
Gastroenterology, Urology
The Water-Induced Thermotherapy System for Benign Prostatic Hyperplasia (product code OEK) is a gastroenterology/urology device used to treat symptomatic BPH through thermotherapy and dilation of prostatic tissue using heated water delivered to the prostatic urethra. The thermal energy induces controlled necrosis of obstructing prostatic tissue to relieve urinary symptoms. This device is FDA Class 2 under regulation 876.4300 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
No 510(k) clearances found for "OEK". 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.