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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

    K040259

    Cited as predicate by: K121914, K162675, K212876

    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
    2024-08-20NAINo action indicatedMasimo Corporation0
    2024-08-20NAINo action indicatedMasimo Corporation0
    2024-03-08NAINo action indicatedMASIMO CORPORATION0
    2024-03-08NAINo action indicatedMASIMO CORPORATION0
    2019-10-15NAINo action indicatedMasimo Corporation, Inc0
    2018-09-13NAINo action indicatedMasimo Corporation0
    2017-05-05NAINo action indicatedMasimo Corporation0
    2014-08-13WLWarning LetterMasimo Corporation—
    2014-03-27VAIVoluntary action indicatedIndustrial Vallera de Mexicali, S. A. de C. V.4
    2013-10-03OAIOfficial action indicatedMasimo Corporation9
    2011-02-11NAINo action indicatedMasimo Corporation0
    2010-02-03NAINo action indicatedMasimo Corporation0
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