Hyperinflation System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K932557 ↗

FDA Product Code

BZR

Device Class

Class II

Regulation

21 CFR Part 868.5330

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Adult Gas Sampling Circuits

  Class I

  FDA 510(k) K932195 Active Cleared 2 Jul 1993

• Coaxial Circuits

  Class I

  FDA 510(k) K932196 Active Cleared 2 Jul 1993

• Volume Ventilators

  Class I

  FDA 510(k) K932560 Active Cleared 22 Jul 1993

• Ventilator Hoses

  Class I

  FDA 510(k) K932563 Active Cleared 16 Jul 1993

• Gas Sampling Lines and Connectors

  Class I

  FDA 510(k) K932562 Active Cleared 23 Jul 1993

• Adult Anesthesia Breathing Circuit

  Class I

  FDA 510(k) K932558 Active Cleared 22 Jul 1993

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