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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: K210073, K210075, K220301, K221121

    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
    2025-08-08OAIOfficial action indicatedFresenius Kabi USA, LLC4
    2025-08-08OAIOfficial action indicatedFresenius Kabi USA, LLC4
    2024-04-16VAIVoluntary action indicatedFresenius Kabi Warrendale0
    2024-02-08VAIVoluntary action indicatedFresenius Kabi USA, LLC0
    2024-01-04WLWarning LetterFresenius Kabi USA, LLC—
    2024-01-04WLWarning LetterFresenius Kabi USA, LLC—
    2023-09-07OAIOfficial action indicatedFresenius Kabi USA, LLC5
    2023-09-07OAIOfficial action indicatedFresenius Kabi USA, LLC5
    2023-08-30VAIVoluntary action indicatedFresenius Kabi USA, LLC1
    2022-03-18VAIVoluntary action indicatedFresenius Kabi USA, LLC1
    2022-03-18VAIVoluntary action indicatedFresenius Kabi USA, LLC1
    2019-11-25NAINo action indicatedFresenius Kabi USA, LLC0
    2018-12-03NAINo action indicatedFresenius Kabi USA LLC0
    2017-09-14NAINo action indicatedFresenius Kabi Warrendale0
    2017-08-18NAINo action indicatedFresenius Kabi USA, LLC0
    2017-08-07NAINo action indicatedFenwal Inc0
    2017-07-20NAINo action indicatedFresenius Kabi USA LLC0
    2016-03-21NAINo action indicatedFenwal International Inc.0
    2015-12-03NAINo action indicatedFresenius Hemocare Deutschland GmbH0
    2015-05-05NAINo action indicatedFresenius Kabi Warrendale0
    2015-01-22NAINo action indicatedFresenius Vial Sa0
    2013-12-11NAINo action indicatedFresenius Kabi USA LLC3
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