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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

    K080387

    Cited as predicate by: K120847, K161103

    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
    2025-07-23VAIVoluntary action indicatedHiossen Inc.1
    2025-07-23VAIVoluntary action indicatedHiossen Inc.1
    2017-04-24NAINo action indicatedHiossen Inc.0
    2017-04-24NAINo action indicatedHiossen Inc.0
    2017-04-12VAIVoluntary action indicatedHiossen Inc.2
    2017-04-12VAIVoluntary action indicatedHiossen Inc.2
    2013-04-18VAIVoluntary action indicatedHiossen Inc.0
    2013-04-18VAIVoluntary action indicatedHiossen Inc.0
    2012-10-05WLWarning LetterHiossen Inc.—
    2012-10-05WLWarning LetterHiossen Inc.—
    2012-05-16OAIOfficial action indicatedHiossen Inc.0
    2012-05-16OAIOfficial action indicatedHiossen Inc.0
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