Madett

• • Terminated Z-0385-2017 FDA Class II ·initiated 27 Oct 2016

  Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

• 7 recalls, same reason

  • Terminated Z-0964-03 FDA Unclassified (pre-2012) ·initiated 6 Jun 2003 ·on shared 510(k) K021044
  • Terminated Z-0967-03 FDA Unclassified (pre-2012) ·initiated 6 Jun 2003 ·on shared 510(k) K021044
  • Terminated Z-0966-03 FDA Unclassified (pre-2012) ·initiated 6 Jun 2003 ·on shared 510(k) K021044
  • Terminated Z-0963-03 FDA Unclassified (pre-2012) ·initiated 6 Jun 2003 ·on shared 510(k) K021044
  • Terminated Z-0965-03 FDA Unclassified (pre-2012) ·initiated 6 Jun 2003 ·on shared 510(k) K021044
  • Terminated Z-0968-03 FDA Unclassified (pre-2012) ·initiated 6 Jun 2003 ·on shared 510(k) K021044
  • Terminated Z-0962-03 FDA Unclassified (pre-2012) ·initiated 6 Jun 2003 ·on shared 510(k) K021044

  Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.

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

510(k) Number

K021044 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Esophageal Intubation Detector Adapter - (Eid-Adapter)

  Class II

  FDA 510(k) K945745 Active Cleared 7 Dec 1994

• Laryngo-Tracheal Mucosal Atomization Device (Madgic)

  Class II

  FDA 510(k) K002255 Active Cleared 18 Sep 2000

• Esophageal Intubation Detector Bulb

  Class II

  FDA 510(k) K942628 Active Cleared 18 Aug 1994

• Esophageal Intubation Detector

  Class II

  FDA 510(k) K990556 Active Cleared 26 Mar 1999