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Duo Flow Catheter-Mc 54

by Medical Components, Inc. United States 510(k)

510(k) K842416 Product code KNZ

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK842416 Date26 Jul 1984ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

11 recalls · FDA

  • 11 recalls, same reason

    • Terminated Z-2942-2018 FDA Class II initiated 12 Jul 2018 via K842416, on the same 510(k)
    • Terminated Z-2937-2018 FDA Class II initiated 12 Jul 2018 via K842416, on the same 510(k)
    • Terminated Z-2935-2018 FDA Class II initiated 12 Jul 2018 via K842416, on the same 510(k)
    • Terminated Z-2941-2018 FDA Class II initiated 12 Jul 2018 via K842416, on the same 510(k)
    • Terminated Z-2940-2018 FDA Class II initiated 12 Jul 2018 via K842416, on the same 510(k)
    • Terminated Z-2936-2018 FDA Class II initiated 12 Jul 2018 via K842416, on the same 510(k)
    • Terminated Z-2939-2018 FDA Class II initiated 12 Jul 2018 via K842416, on the same 510(k)
    • Terminated Z-2933-2018 FDA Class II initiated 12 Jul 2018 via K842416, on the same 510(k)
    • Terminated Z-2934-2018 FDA Class II initiated 12 Jul 2018 via K842416, on the same 510(k)
    • Terminated Z-2938-2018 FDA Class II initiated 12 Jul 2018 via K842416, on the same 510(k)
    • Terminated Z-2932-2018 FDA Class II initiated 12 Jul 2018 via K842416, on the same 510(k)

    The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k) · synced 10 Oct 2026

510(k) Number
FDA Product Code
KNZ
Device Class
Class II
Regulation
21 CFR Part 876.5540
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

From the manufacturer

Manufacturer's product page: Duo-Flow®

Other devices from Medical Components, Inc.

See all devices from Medical Components, Inc. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K842416 24 fields · synced 10 Oct 2026