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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

    K062263

    Cited as predicate by: K102454, K121154, K121520, K122060, K132247, K133105, K170886, K170916, K171549, K202171

    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
    2018-03-02NAINo action indicatedOmron Healthcare Co., Ltd0
    2018-02-27NAINo action indicatedOmron Healthcare Co., Ltd.0
    2018-02-27NAINo action indicatedOmron Healthcare Co., Ltd.0
    2015-05-29VAIVoluntary action indicatedOmron Healthcare Co., Ltd.2
    2015-05-29VAIVoluntary action indicatedOmron Healthcare Co., Ltd.2
    2015-05-26VAIVoluntary action indicatedOmron Healthcare Co., Ltd1
    2012-03-22NAINo action indicatedOmron Healthcare, Inc.0
    2012-03-22NAINo action indicatedOmron Healthcare, Inc.0
    2011-10-06VAIVoluntary action indicatedOmron Healthcare Co., Ltd6
    2011-09-29VAIVoluntary action indicatedOmron Healthcare Co., Ltd.4
    2011-09-29VAIVoluntary action indicatedOmron Healthcare Co., Ltd.4
    2011-05-17NAINo action indicatedOmron Healthcare Inc0
    2011-05-13VAIVoluntary action indicatedOmron Healthcare, Inc.8
    2011-05-13VAIVoluntary action indicatedOmron Healthcare, Inc.8
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