510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K841429Substantially Equivalent

Mouth to Mask Emergency Ventilation

O-Two Systems Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841429 is the FDA 510(k) clearance record for MOUTH TO MASK EMERGENCY VENTILATION, a class I device, cleared for O-Two Systems Intl., Inc. on under FDA product code CAE (Airway, Oropharyngeal, Anesthesiology). FDA records list 14 510(k) clearances for O-Two Systems Intl., Inc., from to . As of , FDA records show no recalls naming K841429.

Clearance record

Decision date
Received
(11 days to decision)
Product code
CAE Airway, Oropharyngeal, Anesthesiology
Regulation
21 CFR 868.5110
Device class
Class I
Review panel
Anesthesiology
Applicant
O-Two Systems Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CAE

Trailing 12 months

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

FDA records show no clearances under product code CAE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CAE, 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