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Modification to Autofuser

by Ace Medical Us, LLC

510(k) K090300

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

16 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK090300 Date30 Apr 2009ClearedStatusActive

Recalls

16 recalls · FDA

  • 16 recalls, same reason

    • Terminated Z-0954-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0949-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0940-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0952-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0942-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0946-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0941-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0950-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0953-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0956-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0943-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0945-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0955-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0948-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0951-2019 FDA Class II initiated 2 Oct 2018
    • Terminated Z-0947-2019 FDA Class II initiated 2 Oct 2018

    Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MEB
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Ace Medical Us, LLC

  • Autofuser

    Class II