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Bleas Esiriuc Anaesthsia System, Models 3000, 2000

by Blease USA, Inc. 510(k)

Active United States

510(k) K051629

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK051629 Date23 Sep 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

3 recalls · FDA

    • Terminated Z-2113-2010 FDA Unclassified (pre-2012) initiated 24 Jun 2010

    Potential for the touch screen on the ventilator portion of the device to go blank when touched. Possibility that this failure may also cause mechanical ventilation to stop.

    • Terminated Z-1408-2010 FDA Unclassified (pre-2012) initiated 26 Mar 2010

    Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. The lower shuttle may become jammed, not permitting flow of anaesthesia gas through the vapouriser. The vapouriser back bar mounting valves will require exchange only on the systems identified in this matter, no other systems are affected.

    • Terminated Z-0813-2011 FDA Unclassified (pre-2012) initiated 25 Jun 2009

    Users may experience difficulty turning the control knob to an active vapour delivery setting, or may not be able to turn on the Left Hand mounted vapouriser on the Blease Sirius Anaesthesia Systems.

Specification

510(k)

510(k) Number
FDA Product Code
BSZ
Device Class
Class II
Regulation
21 CFR Part 868.5160
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Blease USA, Inc.

  • Datum

    Class II