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.
Surveying Laser Product
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The Surveying Laser Product is an instrument that uses laser technology to determine position through the measurement of angles, serving as a precision surveying tool. This product is classified as FDA Not Classified (Class N), meaning it has not been assigned a standard device class under FDA medical device regulations. It carries the product code REP and is GMP-exempt, reflecting that it falls outside the primary medical device regulatory framework. It has no associated medical specialty or regulation number, as it is an industrial or commercial product rather than a medical device. No implant or life-sustaining flags are noted.
No 510(k) clearances found for "REP". 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.