510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922781Substantially Equivalent

Flow Conrol Valve

American Omni Medical, Inc., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922781 is the FDA 510(k) clearance record for FLOW CONROL VALVE, a class II device, cleared for American Omni Medical, Inc. on under FDA product code MJJ (Cpb Check Valve, Retrograde Flow, In-Line). FDA records list 20 510(k) clearances for American Omni Medical, Inc., from to . As of , FDA records show no recalls naming K922781.

Clearance record

Decision date
Received
(272 days to decision)
Product code
MJJ Cpb Check Valve, Retrograde Flow, In-Line
Regulation
21 CFR 870.4400
Device class
Class II
Review panel
Cardiovascular
Applicant
American Omni Medical, Inc. 2930-G Grace Ln., Costa Mesa CA
510(k) summary
Summary
Third party review
No

Clearances, product code MJJ

Trailing 12 months

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

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