Artec Respond Pulmonary Resuscitator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K896886 ↗

FDA Product Code

BTM

Device Class

Class II

Regulation

21 CFR Part 868.5915

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• The Carolina Rocker

  Class I

  FDA 510(k) K900839 Active Cleared 18 Apr 1990

• Artec Twist Valve

  Class I

  FDA 510(k) K830056 Active Cleared 9 Mar 1983

• Mouth to Face Resuscitator

  Class II

  FDA 510(k) K873043 Active Cleared 28 Sep 1987

• Airway Masks

  Class I

  FDA 510(k) K832512 Active Cleared 17 Jan 1984

• Anesthesia Shutoff Valve Positive Closure

  Class I

  FDA 510(k) K854573 Active Cleared 3 Jan 1986

• Raincoat

  Class I

  FDA 510(k) K863910 Active Cleared 20 Oct 1986