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Fresenius Capd Stay.safe Disposable Administration Sets with Stay.safe Connector

by Fresenius Medical Care North America

510(k) K022412

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022412 Date5 Mar 2003ClearedStatusActive

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-1324-2024 FDA Class I initiated 23 Jan 2024
    • Ongoing Z-1326-2024 FDA Class I initiated 23 Jan 2024
    • Ongoing Z-1323-2024 FDA Class I initiated 23 Jan 2024
    • Ongoing Z-1327-2024 FDA Class I initiated 23 Jan 2024
    • Ongoing Z-1325-2024 FDA Class I initiated 23 Jan 2024

    The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

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  • Withdrawn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
KDJ
Device Class
Class II
Regulation
21 CFR Part 876.5630
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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