American Omni Medical, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “American Omni Medical, Inc.” (first 1985, latest 1993), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | 3 | 3 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 | 2 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 | 2 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 2 | 2 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 2 | 2 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (17)
- Anesthesiology (3)
Most recent American Omni Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922781 | FLOW CONROL VALVE | MJJ | 1993-03-08 | 272 |
| K922356 | FLOW CONTROL VALVE, CAT. NO. ACV-38 | MJJ | 1993-02-12 | 269 |
| K900672 | PREBYPASS FILTER, CAT. NO. FPB-5 | KRJ | 1990-04-03 | 49 |
| K884893 | CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 | KRI | 1989-01-30 | 69 |
| K884640 | CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 | KRI | 1989-01-24 | 78 |
| K873316 | BUBBLE TRAP-FILTER CAT. NO B180F37 | DTM | 1988-07-14 | 330 |
| K875080 | AIR VENT LINE CAT. NO. AVL-36 | DTM | 1988-02-29 | 82 |
| K873802 | PRESSURE BARRIER KIT CAT. NO. PBK-3 | DXS | 1987-11-06 | 49 |
| K873610 | PEDIATRIC BUBBLE TRAP CAT. NO. B-100 | BSY | 1987-11-05 | 58 |
| K873488 | SILENT GUARD CAT. NO. SG-10 | DTL | 1987-10-07 | 37 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Omni Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Omni Medical, Inc.?
FDA lists 20 510(k) clearances under the applicant name “American Omni Medical, Inc.” (first 1985, latest 1993), across 12 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by American Omni Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Omni Medical, Inc. is 84 days.
Which FDA product codes appear under American Omni Medical, Inc.?
The most frequent FDA product codes under this applicant name are DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass, 3); BTR (Tube, Tracheal (W/Wo Connector), 2); DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, 2).
Next steps
- See all 20 American Omni Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWD, American Omni Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.