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Edwards Aquarius Hemofiltration System, Model Abm 01

by Edwards Lifesciences Services GmbH

510(k) K070320

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 NumberK070320 Date7 Jun 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0653-2010 FDA Unclassified (pre-2012) initiated 16 Mar 2009

    There have been reports of clinically significant fluid imbalance when a certain level of fluid imbalance is detected the Aquarius will trigger an alarm, however, users are able to override this alarm and continue therapy. It is possible to remove too much fluid from or replace too much fluid to the patient. In extreme cases, this may result in serious injuries or death.

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  • Withdrawn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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