Emergency Tracheostomy Kit

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

510(k) Number

K823872 ↗

FDA Product Code

EWC

Device Class

Class I

Regulation

21 CFR Part 874.1060

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Anesthesia Bacteria Filter

  Class II

  FDA 510(k) K820577 Active Cleared 18 Mar 1982

• Mainflow Bacteria Filter

  Class II

  FDA 510(k) K820576 Active Cleared 18 Mar 1982

• Disposable Bacteria Filter

  Class II

  FDA 510(k) K770136 Active Cleared 14 Feb 1977

• Protect IV Gard

  Class I

  FDA 510(k) K772060 Active Cleared 20 Dec 1977

• Conductive Anesthsia Breath. Circuit

  Class I

  FDA 510(k) K760149 Active Cleared 19 Jul 1976

• Airway, Berman 40, 60, 80, 90, L00MM'S

  Class I

  FDA 510(k) K770001 Active Cleared 12 Jan 1977

See all devices from Omnicon Medical Corp. →