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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Wire, Guide, Catheter, Exempt
Cardiovascular
The Wire, Guide, Catheter (Exempt) is a cardiovascular catheter guidewire used to navigate catheters through the vascular system during interventional procedures. This product code (PTL) is the Class II exempt counterpart of product code DQX, and was exempted from the premarket notification (510(k)) requirement under procedures established by the 21st Century Cures Act, subject to the limitations of exemption in 21 CFR 870.9. As a Class II device under regulation 870.1330, it must still comply with general and special controls but does not require a 510(k) submission as long as it does not exceed the specified limitations. It falls under the Cardiovascular medical specialty and is not flagged as an implant or life-sustaining device.
No 510(k) clearances found for "PTL". 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.