Breathing Circuit Bacteria Filter

• • Terminated Z-0812-2014 FDA Class II ·initiated 26 Dec 2013

  A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result of an internal inspection error and will cause occlusion of gas flow.

510(k) Number

K831856 ↗

FDA Product Code

CAH

Device Class

Class II

Regulation

21 CFR Part 868.5260

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• 1.1, 1.2, 1.3 Temperature Probes

  Class II

  FDA 510(k) K912650 Active Cleared 16 Aug 1991

• Pediatric Anesthesia Circuit

  Class I

  FDA 510(k) K801111 Active Cleared 23 May 1980

• Blood Pressure Cuffs

  Class II

  FDA 510(k) K912638 Active Cleared 25 Jul 1991

• Downs Cap Flow Generator

  Class II

  FDA 510(k) K811393 Active Cleared 9 Jun 1981

• Circuit Anes. Breathing & Components

  Class I

  FDA 510(k) K862003 Active Cleared 7 Jul 1986

• Enflow Iv Fluid Warmer

  Class II

  FDA 510(k) K112902 Active Cleared 14 Mar 2012

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