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Modified Volumetric Infusion Pump

by Mcgaw, Inc.

510(k) K913661

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 ongoing

Recall on shared 510(k) K913661; other models may be affected

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 NumberK913661 Date18 Dec 1991ClearedStatusActive

Recalls

19 recalls · 7 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0707-2026 FDA Class II initiated 29 Oct 2025 on shared 510(k) K913661
    • Ongoing Z-0709-2026 FDA Class II initiated 29 Oct 2025 on shared 510(k) K913661
    • Ongoing Z-0706-2026 FDA Class II initiated 29 Oct 2025 on shared 510(k) K913661
    • Ongoing Z-0716-2026 FDA Class II initiated 29 Oct 2025 on shared 510(k) K913661

    Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

  • 3 recalls, same reason

    • Ongoing Z-2376-2024 FDA Class II initiated 17 Jun 2024 on shared 510(k) K913661
    • Ongoing Z-2377-2024 FDA Class II initiated 17 Jun 2024 on shared 510(k) K913661
    • Ongoing Z-2404-2024 FDA Class II initiated 17 Jun 2024 on shared 510(k) K913661

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

  • 12 recalls, same reason

    • Terminated Z-2556-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661
    • Terminated Z-2554-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661
    • Terminated Z-2555-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661
    • Terminated Z-2550-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661
    • Terminated Z-2545-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661
    • Terminated Z-2558-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661
    • Terminated Z-2549-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661
    • Terminated Z-2547-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661
    • Terminated Z-2546-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661
    • Terminated Z-2557-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661
    • Terminated Z-2544-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661
    • Terminated Z-2551-2021 FDA Class II initiated 10 Aug 2021 on shared 510(k) K913661

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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