Alpha-Omega Services, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Alpha-Omega Services, Inc.” (first 1997, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 244 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 | 2 | 236 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alpha-Omega Services, Inc. took a median 236 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 6 | 6 |
| KXK | Source, Brachytherapy, Radionuclide | 3 | 3 |
Review panels
- Radiology (9)
Most recent Alpha-Omega Services, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233628 | AOS Interstitial Templates, Needles, and Accessories | JAQ | 2024-07-10 | 240 |
| K233626 | AOS Marker Seeds (SMG0242-025) | JAQ | 2024-07-02 | 232 |
| K102811 | AOS ORION IR-192 SOURCE CABLE | KXK | 2011-06-02 | 247 |
| K062824 | AOS UNIVERSAL CONECTING GUIDE TUBE | JAQ | 2007-07-03 | 286 |
| K062823 | AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES | JAQ | 2007-05-29 | 251 |
| K062826 | AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS | JAQ | 2007-05-22 | 244 |
| K062825 | AOS MARKER SEEDS | KXK | 2007-05-22 | 244 |
| K991571 | 10 CURIE IRDIUM 192, CSN00100-192 | KXK | 2000-02-22 | 293 |
| K964910 | AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS | JAQ | 1997-03-10 | 91 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-09-04.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Alpha-Omega Services, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Alpha-Omega Services, Inc.” (first 1997, latest 2024), across 2 product codes in 1 review panel. 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 Services, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alpha-Omega Services, Inc. is 244 days.
Which FDA product codes appear under Alpha-Omega Services, Inc.?
The most frequent FDA product codes under this applicant name are JAQ (System, Applicator, Radionuclide, Remote-Controlled, 6); KXK (Source, Brachytherapy, Radionuclide, 3).
Next steps
- See all 9 Alpha-Omega Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAQ, Alpha-Omega Services, 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.