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Fresenius Sterile Stay Safe Cap

by Fresenius Medical Care North America

510(k) K083542

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083542 Date29 Dec 2008ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0507-2024 FDA Class II initiated 10 Oct 2023

    Updating the labeling to include additional warnings and contraindications for potential side effects.

    • Terminated Z-2090-2021 FDA Class II initiated 28 Apr 2021

    Exposed to freezing temperatures due to refrigerated truck malfunctions

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  • Withdrawn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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