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.
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Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Unknown
A totally implanted spinal cord stimulator for pain relief is a surgically implanted neurostimulation system that delivers electrical impulses to the spinal cord to modulate pain signals, used in patients with chronic intractable pain conditions such as failed back surgery syndrome or complex regional pain syndrome. The device is FDA Class 3, the highest risk category, requiring Pre-Market Approval (PMA) to demonstrate safety and effectiveness before marketing. It carries product code LGW and no specific 21 CFR regulation number or medical specialty is recorded. This device is flagged as an implant, as it is surgically placed within the body.
No 510(k) clearances found for "LGW". 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.