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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Nitric Oxide Generator And Delivery System
Unknown
The Nitric Oxide Generator and Delivery System is a device that generates and delivers nitric oxide (NO) gas at the point of care for use in conjunction with ventilatory support to treat hypoxic respiratory failure associated with pulmonary hypertension in term and near-term neonates (greater than 34 weeks gestation). The system includes an integrated backup NO delivery system and gas analyzers with alarms for monitoring of delivered NO, nitrogen dioxide, and oxygen levels. Classified as FDA Class 3 requiring Premarket Approval (PMA) and reviewed under Anesthesiology, it is flagged as life-sustaining given its critical role in neonatal respiratory therapy. No regulation number is assigned.
No 510(k) clearances found for "QTB". 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.