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Clirans E-Series Hollow Fiber Dialyzers

by Terumo Medical Corp.

510(k) K003425

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK003425 Date1 Feb 2001ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0792-05 FDA Unclassified (pre-2012) initiated 31 Mar 2005
    • Terminated Z-0791-05 FDA Unclassified (pre-2012) initiated 31 Mar 2005

    Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.

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  • Withdrawn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
KDI
Device Class
Class II
Regulation
21 CFR Part 876.5860
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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