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.
Pacemaker/Icd/Crt Non-Implanted Components
Unknown
The Pacemaker/ICD/CRT Non-Implanted Components (product code OSR) are external components that provide programming, interrogation, printing, remote monitoring, and communication between a cardiac pulse generator and the health care provider. These components enable clinicians to configure and monitor implanted cardiac rhythm management devices. As an FDA Class 3 device without an assigned regulation number, it requires Premarket Approval (PMA) to demonstrate safety and effectiveness, and is reviewed by the Cardiovascular panel. Despite being non-implanted components, the product code is flagged as implant-associated due to the broader system it supports. It is not flagged as life-sustaining.
No 510(k) clearances found for "OSR". 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.