510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K851194Substantially Equivalent

Ambu CPAP System

Ambu, Inc., Danbury CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851194 is the FDA 510(k) clearance record for AMBU CPAP SYSTEM, a class II device, cleared for Ambu, Inc. on under FDA product code BYE (Attachment, Breathing, Positive End Expiratory Pressure). FDA records list 2 510(k) clearances for Ambu, Inc., from to . As of , FDA records show no recalls naming K851194.

Clearance record

Decision date
Received
(20 days to decision)
Product code
BYE Attachment, Breathing, Positive End Expiratory Pressure
Regulation
21 CFR 868.5965
Device class
Class II
Review panel
Anesthesiology
Applicant
Ambu, Inc. 7 Old Sherman Tpke., Danbury CT
Third party review
No

Clearances, product code BYE

Trailing 12 months

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

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