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.
Cranial Surgical Planning And Instrument Guides
Neurology
The Cranial Surgical Planning and Instrument Guides system consists of software and hardware for neurosurgical planning, used to create patient-specific anatomical models, surgical templates, and guides for marking or cutting cranial bone in neurosurgical procedures. It is classified as FDA Class 2 under 21 CFR 882.4310 in the Neurology specialty, requiring 510(k) premarket notification. The device assists surgeons in precise cranial access planning based on pre-operative imaging. Product code PPT; not an implant and not life-sustaining.
510(k) Clearances
4 matchesWhat 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.