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Triton Meidcal Tmed IV-Set

by Triton Medical, LLC

510(k) K073444

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

15 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 · Traditional NumberK073444 Date18 Aug 2008ClearedStatusActive

Recalls

15 recalls · FDA

  • 15 recalls, same reason

    • Terminated Z-2234-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2231-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2221-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2235-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2233-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2222-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2229-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2225-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2226-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2227-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2230-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2224-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2232-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2228-2016 FDA Class II initiated 14 Jun 2016
    • Terminated Z-2223-2016 FDA Class II initiated 14 Jun 2016

    WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent