510(k) Report

FDA applicant

American Omni Medical, Inc.

Costa Mesa, CA20 decisions1985–19930 recalls

FDA records 20 decisions for American Omni Medical, Inc. (Costa Mesa, CA) from 1985 to 1993: 20 510(k) clearances. Most are in product codes DWD (Suction Control, Intracardiac, Cardiopulmonary…) and DTL (Adaptor, Stopcock, Manifold, Fitting…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided American Omni Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Omni Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Omni Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DWDSuction Control, Intracardiac, Cardiopulmonary Bypass3decisions
  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass2decisions
  • BTRTube, Tracheal (W/Wo Connector)2decisions
  • MJJCpb Check Valve, Retrograde Flow, In-Line2decisions
  • KRIAccessory Equipment, Cardiopulmonary Bypass2decisions
  • KRJFilter, Prebypass, Cardiopulmonary Bypass2decisions

Also: DTM (2), CAC (1), BSY (1), DXS (1), DTW (1), DWF (1).

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K922356Flow Control Valve, Cat. NO. Acv-38American Omni Medical, Inc. · 19933cite it
  • K861428Suction Control Valve (Nonadjustable) Cat.RLV-2100American Omni Medical, Inc. · 19861cites it

What has FDA decided for it lately?

  • K922781Flow Conrol ValveAmerican Omni Medical, Inc. · 1993
  • K922356Flow Control Valve, Cat. NO. Acv-38American Omni Medical, Inc. · 1993
  • K900672Prebypass Filter, Cat. NO. FPB-5American Omni Medical, Inc. · 1990
  • K884893Cardiotomy Reservoir Valve NO. CRV-30 or PCRV-25American Omni Medical, Inc. · 1989
  • K884640Cardioplegia Overpressure Valve Cpop-350 & 700American Omni Medical, Inc. · 1989
  • K873316Bubble Trap-Filter Cat. NO B180F37American Omni Medical, Inc. · 1988
  • K875080Air Vent Line Cat. NO. Avl-36American Omni Medical, Inc. · 1988
  • K873802Pressure Barrier Kit Cat. NO. PBK-3American Omni Medical, Inc. · 1987

All 20 as American Omni Medical, Inc. →