510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921125Substantially Equivalent

Ambu Oxygen Regulator

Amg, LLC, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921125 is the FDA 510(k) clearance record for AMBU OXYGEN REGULATOR, a class I device, cleared for Amg, LLC on under FDA product code CAN (Regulator, Pressure, Gas Cylinder). FDA records list one 510(k) clearance for Amg, LLC. As of , FDA records show no recalls naming K921125.

Clearance record

Decision date
Received
(191 days to decision)
Product code
CAN Regulator, Pressure, Gas Cylinder
Regulation
21 CFR 868.2700
Device class
Class I
Review panel
Anesthesiology
Applicant
Amg, LLC 8904 Bash St., Suite A, Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code CAN

Trailing 12 months

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

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