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.
Implant, Anti-Gastroesophageal Reflux
Unknown
An anti-gastroesophageal reflux implant is a surgically placed device designed to augment or restore the function of the lower esophageal sphincter, preventing acid reflux from the stomach into the esophagus in patients with chronic gastroesophageal reflux disease (GERD). It is classified as FDA Class 3, the highest risk category, requiring a Premarket Approval (PMA) application with full clinical safety and effectiveness data before marketing. The product code is LEI, with no regulation number or medical specialty formally assigned. This device is flagged as an implant.
No 510(k) clearances found for "LEI". 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.