Skip to content
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

    K070566

    Cited as predicate by: K093788, K102968, K152407

    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
    2024-11-27NAINo action indicatedDraeger Medical Systems, Inc.0
    2024-11-27NAINo action indicatedDraeger Medical Systems, Inc.0
    2022-08-15NAINo action indicatedDraeger Medical Systems, Inc.0
    2022-08-15NAINo action indicatedDraeger Medical Systems, Inc.0
    2022-04-21VAIVoluntary action indicatedDraeger Medical Systems, Inc.2
    2022-04-21VAIVoluntary action indicatedDraeger Medical Systems, Inc.2
    2020-01-17WLWarning LetterDraeger Medical Systems, Inc.—
    2020-01-17WLWarning LetterDraeger Medical Systems, Inc.—
    2019-09-20OAIOfficial action indicatedDraeger Medical Systems, Inc.0
    2019-09-20OAIOfficial action indicatedDraeger Medical Systems, Inc.0
    2013-07-03VAIVoluntary action indicatedDraeger Medical Systems, Inc.1
    2013-07-03VAIVoluntary action indicatedDraeger Medical Systems, Inc.1
    2013-04-12VAIVoluntary action indicatedDraeger Medical Systems, Inc.0
    2013-04-12VAIVoluntary action indicatedDraeger Medical Systems, Inc.0
    Similar devices
    Select up to two to place side-by-side with this device.