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.
Let the assistant find your predicates
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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Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
Gastroenterology, Urology
The Ultrafiltration-Controlled Nocturnal Dialysate Delivery System (product code ODN) is a gastroenterology/urology device used to perform hemodialysis at night using a high-permeability hemodialyzer and an ultrafiltration-controlled system, indicated for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis). Nocturnal dialysis schedules can improve patient tolerability and clinical outcomes. This device is FDA Class 2 under regulation 876.5860 in the Gastroenterology, Urology specialty, requires 510(k) clearance, and is notably flagged as life-sustaining, reflecting its role in maintaining life for dialysis-dependent patients. It carries no implant flag.
510(k) Clearances
2 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.