510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770001Substantially Equivalent

Airway, Berman 40, 60, 80, 90, L00mm's

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

K770001 is the FDA 510(k) clearance record for AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S, a class I device, cleared for Omnicon Medical Corp. on under FDA product code CAE (Airway, Oropharyngeal, Anesthesiology). FDA records list 10 510(k) clearances for Omnicon Medical Corp., from to . As of , FDA records show no recalls naming K770001.

Clearance record

Decision date
Received
(9 days to decision)
Product code
CAE Airway, Oropharyngeal, Anesthesiology
Regulation
21 CFR 868.5110
Device class
Class I
Review panel
Anesthesiology
Applicant
Omnicon Medical Corp.
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