Pulmanex Tm (Neo-natal Size)

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

510(k) Number

K884068 ↗

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

• Pulmanex

  Class II

  FDA 510(k) K854037 Active Cleared 1 Nov 1985

• Cushion Flex(Tm)

  Class I

  FDA 510(k) K884387 Active Cleared 17 Nov 1988

See all devices from Life Design Systems, Inc. →

• What is the PULMANEX TM (NEO-NATAL SIZE) used for?

  The PULMANEX TM (NEO-NATAL SIZE) is a manual resuscitator designed for emergency ventilation support, as defined in its device name and openfda fields, providing manual ventilation in emergency situations.

• Is the PULMANEX TM (NEO-NATAL SIZE) supplied sterile or non-sterile, and is it intended for single use or reuse?

  The device is supplied non-sterile and is intended for reuse after appropriate cleaning and disinfection, as indicated by its manual resuscitator nature and the absence of single-use labeling in the provided data.

• What regulatory pathway was used to clear the PULMANEX TM (NEO-NATAL SIZE), and what is its classification?

  The PULMANEX TM (NEO-NATAL SIZE) was cleared via the FDA 510(k) process under K884068 with a decision date of 1988-11-16 and is classified as a Class II device, based on the substantially equivalent determination in the device data.