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.
Microscopy Laser Instrument Or Accessory Products
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The Microscopy Laser Instrument or Accessory Product is a laser product used for microscopic studies of samples or as a laser accessory for microscope systems, enabling applications such as confocal microscopy, fluorescence microscopy, and laser scanning microscopy. It is classified as FDA Not Classified (Class N) with product code RIB and is GMP-exempt. This product has no associated regulation number or medical specialty under the medical device framework, as it is used primarily in research and scientific laboratory settings. No implant or life-sustaining flags are noted. FDA oversight applies under electronic product radiation control provisions for laser-based scientific instruments.
No 510(k) clearances found for "RIB". 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.