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.
Eating Disorder Conditioning Tool
Neurology
The Eating Disorder Conditioning Tool (product code OBV) is a neurological medical device that non-invasively measures the mass of food consumed during a meal and provides real-time feedback on eating rate, patient satiety, and eating patterns to support behavioral modification in patients with eating disorders. It is intended as a therapeutic conditioning aid rather than a diagnostic device. This device is FDA Class 2 under regulation 882.5060 in the Neurology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
510(k) Clearances
1 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.