Patient Circuit Manifold

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781485 ↗

FDA Product Code

CAF

Device Class

Class II

Regulation

21 CFR Part 868.5630

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• FLEXTUBES:9, 20, 26

  Class I

  FDA 510(k) K781428 Active Cleared 11 Sep 1978

• Model Ls-80 Adult Ventilation Monitor

  Class II

  FDA 510(k) K781515 Active Cleared 2 Oct 1978

• Newbourns Infant Ventilator

  Class II

  FDA 510(k) K802051 Active Cleared 3 Oct 1980

• Model Bp-200 Infant Pressure Ventilator

  Class II

  FDA 510(k) K801697 Active Cleared 7 Aug 1980

• Humidifiers, Model:ls-420 and Ls-460

  Class II

  FDA 510(k) K781760 Active Cleared 20 Dec 1978

• Ventilator Model BV-300 Infant

  Class II

  FDA 510(k) K790199 Active Cleared 13 Apr 1979

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