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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System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
Unknown
The Colorectal Neoplasia DNA Methylation and Hemoglobin Detection System is a qualitative, non-invasive screening device that detects methylation of specific DNA markers associated with colorectal cancer and the presence of occult hemoglobin in specimens including stool, blood, urine, and buccal swabs, intended as an aid in detecting colorectal cancer or advanced adenomas in conjunction with diagnostic colonoscopy. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA), reviewed by the Pathology (PA) panel with no assigned regulation number. The product code is PHP, and the device is indicated for average-risk adults aged 50 and older.
No 510(k) clearances found for "PHP". 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.