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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

    Predicate lineage

    Cited as predicate by: K182219, K192274, K192614, K200817, K203360, K203554, K210161, K210903, K211090, K212364, K212702, K221684, K221866, K222738, K223924, K231429, K231874, K232220, K232268, K232560, K233167, K233194, K240091, K241616, K242379, K251427

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record

    None in the loaded window.

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