510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823872Substantially Equivalent

Emergency Tracheostomy Kit

Omnicon Medical Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823872 is the FDA 510(k) clearance record for EMERGENCY TRACHEOSTOMY KIT, a class I device, cleared for Omnicon Medical Corp. on under FDA product code EWC (Chamber, Acoustic (For Audiometric Testing)). FDA records list 10 510(k) clearances for Omnicon Medical Corp., from to . As of , FDA records show no recalls naming K823872.

Clearance record

Decision date
Received
(25 days to decision)
Product code
EWC Chamber, Acoustic (For Audiometric Testing)
Regulation
21 CFR 874.1060
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Omnicon Medical Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EWC

Trailing 12 months

FDA records hold no clearances under product code EWC in the trailing twelve months.

FDA records show no clearances under product code EWC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EWC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260