510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864503Substantially Equivalent

Modified Rlv-2100 B

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

K864503 is the FDA 510(k) clearance record for MODIFIED RLV-2100 B, a class II device, cleared for American Omni Medical, Inc. on under FDA product code DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass). FDA records list 20 510(k) clearances for American Omni Medical, Inc., from to . As of , FDA records show no recalls naming K864503.

Clearance record

Decision date
Received
(53 days to decision)
Product code
DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
Regulation
21 CFR 870.4430
Device class
Class II
Review panel
Cardiovascular
Applicant
American Omni Medical, Inc. 2930-G Grace Ln., Costa Mesa CA
Third party review
No

Clearances, product code DWD

Trailing 12 months

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

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