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.
Free to try · every answer cites its records
Hyaline Membrane Disease Assay
Unknown
The Hyaline Membrane Disease Assay is a diagnostic device used to assess fetal lung maturity by measuring components in amniotic fluid or related specimens that indicate the risk of hyaline membrane disease (respiratory distress syndrome) in the newborn, typically used in the management of preterm labor. It is classified as a Class 3 (highest risk) device under FDA regulations, requiring Premarket Approval (PMA) given the critical clinical consequences of inaccurate assessment of neonatal lung maturity. The product code is LTC; no regulation number or specific medical specialty code is on file. No special flags apply to this device.
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.