PULMANEX

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

510(k) Number

K854037 ↗

FDA Product Code

BTM

Device Class

Class II

Regulation

21 CFR Part 868.5915

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Headstrap

  Class I

  FDA 510(k) K854537 Active Cleared 3 Dec 1985

• Modified Cushion-Flex(Tm)

  Class I

  FDA 510(k) K890108 Active Cleared 24 Jan 1989

• Modification Manual Pulmon Resuscitor/Pulmanex(Tm)

  Class II

  FDA 510(k) K913714 Active Cleared 1 Dec 1992

• Flow Generator for Sleep Apnea, Lds 1500

  Class II

  FDA 510(k) K862448 Active Cleared 14 Nov 1986

• Cushion Flex(Tm)

  Class I

  FDA 510(k) K884387 Active Cleared 17 Nov 1988

• Filter-Flex

  Class II

  FDA 510(k) K841236 Active Cleared 5 Apr 1984

See all devices from Life Design Systems, Inc. →

• What is the PULMANEX device used for?

  The PULMANEX is a Class 2 manual ventilator emergency resuscitator device specifically designed for use in anesthesiology to provide manual ventilation assistance during emergency situations when mechanical ventilation may not be available.

• Is the PULMANEX device single-use or reusable?

  The device data does not specify whether the PULMANEX is intended for single-use or reuse. This information would need to be confirmed with the manufacturer, Life Design Systems, Inc., or through the device's instructions for use.

• What is the regulatory status of the PULMANEX device?

  The PULMANEX device was cleared through the Traditional 510(k) pathway by the FDA on November 1, 1985, with the K number K854037. It is classified as a Class 2 device and is substantially equivalent to other devices in its product code category (BTM).

• What are the specifications of the PULMANEX device?

  The PULMANEX is a manual ventilator emergency resuscitator device with no specific measurements or technical details provided in the data. It is manufactured by Life Design Systems, Inc. and is designed for emergency ventilation assistance in anesthesiology settings.