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.
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Unknown
The Automatic Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D) is an implantable device indicated for patients who need an ICD and also have moderate to severe heart failure requiring cardiac resynchronization therapy, delivering both defibrillation and synchronized biventricular pacing. It is classified as FDA Class 3 (Premarket Approval), the most stringent regulatory category requiring PMA approval demonstrating safety and effectiveness, under product code NIK in the Cardiovascular review panel (no regulation number assigned). This device is flagged as both an implant and life-sustaining/life-supporting, reflecting its critical therapeutic role in managing life-threatening cardiac arrhythmias and heart failure.
No 510(k) clearances found for "NIK". 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.