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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

    K032503

    Cited as predicate by: K142368

    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
    2023-07-20NAINo action indicatedPentax of America Inc0
    2018-09-27VAIVoluntary action indicatedPentax of America Inc5
    2016-03-11NAINo action indicatedPENTAX of America Inc0
    2015-08-12WLWarning LetterPentax of America Inc—
    2015-04-02OAIOfficial action indicatedPentax of America Inc0
    2014-12-17VAIVoluntary action indicatedPentax of America Inc2
    2014-07-28NAINo action indicatedPENTAX of America Inc0
    2013-03-29WLWarning LetterPentax of America Inc—
    2012-12-18OAIOfficial action indicatedPentax of America Inc4
    2011-03-17VAIVoluntary action indicatedPentax of America Inc3
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