Alpha Omega , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Alpha Omega , Ltd.” (first 2000, latest 2007), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 166 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 |
|---|---|---|---|
| GZL | Electrode, Depth | 3 | 3 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
Review panels
- Neurology (4)
- Cardiovascular (1)
Most recent Alpha Omega , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071697 | NEURONAV SYSTEM AND NEURONAV DRIVE | GZL | 2007-12-03 | 166 |
| K051830 | NEURODRIVE SYSTEM | GZL | 2005-09-16 | 72 |
| K013396 | ALPHA DRIVE SYSTEM | HAW | 2002-08-07 | 296 |
| K001520 | ALPHA OMEGA DUAL COOLER-HEATER | DWC | 2000-11-22 | 190 |
| K993622 | NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY | GZL | 2000-01-24 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Alpha Omega , Ltd..
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.
- Alpha Unlimited, Inc. (10 510(k)s)
- Alpha Omega Engineering , Ltd. (9 510(k)s)
- Alpha Therapeutic Corp. (8 510(k)s)
- Alpha Gamma Laboratory (4 510(k)s)
- Alpha Orthopaedics (3 510(k)s)
- Alpha Dent Implants GmbH (2 510(k)s)
- Alpha Intelligence Manifolds, Inc. (2 510(k)s)
- Alpha Medical Systems (2 510(k)s)
- Alpha Protech, Inc. (2 510(k)s)
- Alpha Surgical, Inc. (2 510(k)s)
- Alpha Antigens, Inc. (1 510(k)s)
- Alpha Glove Sdn. Bhd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alpha Omega , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Alpha Omega , Ltd.” (first 2000, latest 2007), across 3 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 Alpha Omega , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alpha Omega , Ltd. is 166 days.
Which FDA product codes appear under Alpha Omega , Ltd.?
The most frequent FDA product codes under this applicant name are GZL (Electrode, Depth, 3); DWC (Controller, Temperature, Cardiopulmonary Bypass, 1); HAW (Neurological Stereotaxic Instrument, 1).
Next steps
- See all 5 Alpha Omega , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GZL, Alpha Omega , Ltd.'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.