Spiro-Flex

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K945565 ↗

FDA Product Code

CAI

Device Class

Class I

Regulation

21 CFR Part 868.5240

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Anesthesia Breathing Circuit

  Class I

  FDA 510(k) K900594 Active Cleared 15 Mar 1990

• Aeromist II Nebulizer

  Class II

  FDA 510(k) K901315 Active Cleared 10 Sep 1990

• Sterilization of Devices by Radiation

  Class II

  FDA 510(k) K874659 Active Cleared 2 Feb 1988

• Thermo-Flow Set

  Class II

  FDA 510(k) K914686 Active Cleared 15 Apr 1992

• Filt-R-All Bacterial Filter

  Class II

  FDA 510(k) K896832 Active Cleared 22 Jan 1990

• Filt-R-All Bacterial/Viral Filter

  Class II

  FDA 510(k) K900990 Active Cleared 19 Apr 1990