American Omni Medical, Inc.
Costa Mesa, CA, US
American Omni Medical, Inc. appears in FDA device records in Costa Mesa, CA. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for American Omni Medical, Inc. between 1985 and 1993. The busiest year on record is 1987, with 7. The most recent is 1993, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 4 |
| 1986 | 2 |
| 1987 | 7 |
| 1988 | 2 |
| 1989 | 2 |
| 1990 | 1 |
| 1993 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K922781 | FLOW CONROL VALVE | MJJ | Substantially Equivalent | |
| K922356 | FLOW CONTROL VALVE, CAT. NO. ACV-38 | MJJ | Substantially Equivalent | |
| K900672 | PREBYPASS FILTER, CAT. NO. FPB-5 | KRJ | Substantially Equivalent | |
| K884893 | CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 | KRI | Substantially Equivalent | |
| K884640 | CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 | KRI | Substantially Equivalent | |
| K873316 | BUBBLE TRAP-FILTER CAT. NO B180F37 | DTM | Substantially Equivalent | |
| K875080 | AIR VENT LINE CAT. NO. AVL-36 | DTM | Substantially Equivalent | |
| K873802 | PRESSURE BARRIER KIT CAT. NO. PBK-3 | DXS | Substantially Equivalent | |
| K873610 | PEDIATRIC BUBBLE TRAP CAT. NO. B-100 | BSY | Substantially Equivalent | |
| K873488 | SILENT GUARD CAT. NO. SG-10 | DTL | Substantially Equivalent | |
| K871632 | NASOGASTRIC VOICETUBE | BTR | Substantially Equivalent | |
| K871350 | PREBYPASS FILTER | KRJ | Substantially Equivalent | |
| K870819 | BUBBLE TRAP CAT. NO. B-180 | DWF | Substantially Equivalent | |
| K864503 | MODIFIED RLV-2100 B | DWD | Substantially Equivalent | |
| K862950 | WHITE-SIPOSS TUBE, CAT NO WS-1 | BTR | Substantially Equivalent | |
| K861428 | SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 | DWD | Substantially Equivalent | |
| K852178 | EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS | CAC | Substantially Equivalent | |
| K852407 | SENSOR TAPE CAT. NO. ST-45 | DTW | Substantially Equivalent | |
| K851465 | SILENT GUARD CAT. NO. SG-30 | DTL | Substantially Equivalent | |
| K851406 | AJDJUSTABLE SUCTION CONTROL VALVE | DWD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CACApparatus, Autotransfusion
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- BSYCatheters, Suction, Tracheobronchial
- MJJCpb Check Valve, Retrograde Flow, In-Line
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- KRJFilter, Prebypass, Cardiopulmonary Bypass
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass
- BTRTube, Tracheal (W/Wo Connector)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain