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Isothermal Heated Ventilator & Anesthesia Circuit

by Baxter Healthcare Corp

510(k) K915226

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK915226 Date12 Jan 1993ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-2689-2014 FDA Class II initiated 31 Jul 2014

    The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.

  • 3 recalls, same reason

    • Terminated Z-1899-2012 FDA Class I initiated 29 May 2012
    • Terminated Z-1901-2012 FDA Class I initiated 29 May 2012
    • Terminated Z-1900-2012 FDA Class I initiated 29 May 2012

    The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.

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  • Withdrawn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
BZE
Device Class
Class II
Regulation
21 CFR Part 868.5270
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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