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Frsenius Pd Iqcard Cycler

by Fresenius Medical Care North America

510(k) K002892

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK002892 Date5 Apr 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0834-06 FDA Unclassified (pre-2012) initiated 22 Mar 2006

    Stay safe trigger body may not connect to the extension set and result in associated peritonitis

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  • Withdrawn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

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