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Servo Ventilator 300

by Siemens Life Support Systems

510(k) K902859

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK902859 Date26 Apr 1991ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0588-2010 FDA Unclassified (pre-2012) initiated 17 Nov 2009

    Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.

    • Terminated Z-1252-2009 FDA Unclassified (pre-2012) initiated 23 Mar 2009

    The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.

    • Terminated Z-0571-05 FDA Unclassified (pre-2012) initiated 3 Jan 2005

    Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.

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  • Withdrawn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
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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