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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

    K950866

    Cited as predicate by: K093738

    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
    DateTypeOutcomeFacilityCitations
    2025-07-10NAINo action indicatedDecimal LLC0
    2023-10-20NAINo action indicatedQFIX0
    2022-11-09NAINo action indicatedDecimal LLC0
    2018-09-24NAINo action indicatedQFIX0
    2018-02-23VAIVoluntary action indicatedDecimal LLC3
    2016-02-10NAINo action indicatedMedTec LLC0
    2016-02-10NAINo action indicatedMedTec LLC0
    2015-05-01VAIVoluntary action indicatedDecimal LLC0
    2012-06-29VAIVoluntary action indicatedDecimal LLC6
    2011-01-07NAINo action indicatedMedTec LLC0
    2011-01-07NAINo action indicatedMedTec LLC0
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