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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

    Cited as predicate by: K172554

    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
    2023-06-14NAINo action indicatedFIRST WATER RAMSBURY, LTD0
    2023-05-11VAIVoluntary action indicatedManukaMed Limited Partnership4
    2019-12-16VAIVoluntary action indicatedGentell1
    2019-12-12VAIVoluntary action indicatedGentell, Inc8
    2019-12-12VAIVoluntary action indicatedGentell, Inc8
    2017-02-09NAINo action indicatedDerma Sciences Canada, Inc.0
    2016-12-13VAIVoluntary action indicatedGentell, Inc11
    2016-12-13VAIVoluntary action indicatedGentell, Inc11
    2015-10-05WLWarning LetterGentell, Inc—
    2015-10-05WLWarning LetterGentell, Inc—
    2015-08-25OAIOfficial action indicatedGentell, Inc17
    2015-08-25OAIOfficial action indicatedGentell, Inc17
    2014-07-10NAINo action indicatedDerma Sciences Nantong Inc0
    2014-03-13NAINo action indicatedDerma Sciences Canada, Inc.0
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