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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: K113010, K120054, K171978

    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
    2024-05-30NAINo action indicatedDeVilbiss Healthcare LLC0
    2022-08-17OAIOfficial action indicatedDeVilbiss Healthcare LLC4
    2021-11-23WLWarning LetterDeVilbiss Healthcare LLC—
    2021-08-25OAIOfficial action indicatedDeVilbiss Healthcare LLC9
    2016-02-24VAIVoluntary action indicatedDrive DeVilbiss Healthcare0
    2016-01-28NAINo action indicatedDeVilbiss Healthcare LLC0
    2014-07-18VAIVoluntary action indicatedDrive DeVilbiss Healthcare3
    2012-10-10WLWarning LetterDrive DeVilbiss Healthcare—
    2012-08-31OAIOfficial action indicatedDrive DeVilbiss Healthcare8
    2012-02-22NAINo action indicatedDeVilbiss Healthcare LLC0
    2010-03-31NAINo action indicatedDeVilbiss Healthcare LLC0
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