Guardian Neonate Cpap/Humidification System

• • Terminated Z-0717-06 FDA Unclassified (pre-2012) ·initiated 27 Dec 2005 ·on shared 510(k) K040862

  Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.

• • Terminated Z-1191-06 FDA Unclassified (pre-2012) ·initiated 19 Sep 2005 ·on shared 510(k) K040862

  Gas input pressures over 62 psi may cause CPAP pressure oscillation

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K040862 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Criterion 60 or Pm 60

  Class II

  FDA 510(k) K000959 Active Cleared 22 Jun 2000

• Criterion 40 OR PM 40

  Class II

  FDA 510(k) K992101 Active Cleared 6 Jan 2000

• Whisperflow Oxygen Flow Generator - Adjustable Model Wf 8500 Whisperflow Oxygen Flow Generator - Fixed Model Wf 8530 Wh

  Class II

  FDA 510(k) K982283 Active Cleared 9 Mar 1999

• Oxicheck

  Class II

  FDA 510(k) K023565 Active Cleared 28 Mar 2003