# American Omni Medical, Inc.

- Location (FDA's records): Costa Mesa, CA
- FDA decisions: 20 (1985–1993): 20 510(k) clearances
- Product codes: DWD (3), DTL (2), BTR (2), MJJ (2), KRI (2), KRJ (2), DTM (2), CAC (1), BSY (1), DXS (1), DTW (1), DWF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Quest Medical, Inc.: 1 (https://510kreport.com/company/quest-medical)
- Terumo Cardiovascular Systems Corp.: 1 (https://510kreport.com/company/terumo-cardiovascular-systems)
- Js Vascular, Inc.: 1 (https://510kreport.com/company/js-vascular)
- Cobe Cardiovascular, Inc.: 1 (https://510kreport.com/company/cobe-cardiovascular)

## Its most-cited devices
- K922356: Flow Control Valve, Cat. NO. Acv-38 (1993), cited by 3
- K861428: Suction Control Valve (Nonadjustable) Cat.RLV-2100 (1986), cited by 1

## Recent decisions
- K922781: Flow Conrol Valve (Mar 8, 1993)
- K922356: Flow Control Valve, Cat. NO. Acv-38 (Feb 12, 1993)
- K900672: Prebypass Filter, Cat. NO. FPB-5 (Apr 3, 1990)
- K884893: Cardiotomy Reservoir Valve NO. CRV-30 or PCRV-25 (Jan 30, 1989)
- K884640: Cardioplegia Overpressure Valve Cpop-350 & 700 (Jan 24, 1989)
- K873316: Bubble Trap-Filter  Cat. NO B180F37 (Jul 14, 1988)
- K875080: Air Vent Line Cat. NO. Avl-36 (Feb 29, 1988)
- K873802: Pressure Barrier Kit Cat. NO. PBK-3 (Nov 6, 1987)

Source page: https://510kreport.com/company/american-omni-medical