Who cited your device as a 510(k) predicate?
Every 510(k) names the legally marketed device its sponsor claims substantial equivalence to. When that device is yours, a competitor has publicly declared they are entering your market. FDA does not publish predicate citations as data — they exist only as text inside each submission's PDF, so they cannot be looked up in the FDA database or by any general search tool. We parsed the documents so they can be.
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From this month's data
Imricor Medical Systems cleared the NorthStar Mapping System, citing Biosense Webster's CARTO 3 EP Navigation System as its predicate.
K252164 → K231207 · verifiable against FDA records, absent from every FDA search
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Describe a device in plain language and see the cleared devices most likely to serve as predicates, with the reasoning shown. Embeddings run in your browser.
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