Alphatek Corp.: FDA clearances and approvals
Alphatek Corp. has 5 FDA 510(k) clearances (first 1992, latest 2003), across 1 product code in 1 review panel. Median 510(k) review time: 87 days.
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 |
|---|---|---|---|
| IXW | Processor, Radiographic-Film, Automatic | 5 | 5 |
Review panels
- Radiology (5)
Most recent Alphatek Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023613 | AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 | IXW | 2003-01-23 | 87 |
| K931883 | AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033 | IXW | 1993-08-23 | 131 |
| K931882 | MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR | IXW | 1993-08-23 | 131 |
| K925569 | AX-700LE AUTOMATIC X-RAY FILM PROCESSOR | IXW | 1993-01-15 | 73 |
| K924430 | AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 | IXW | 1992-11-27 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Alphatek Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Alphatek Corp. have?
Alphatek Corp. has 5 FDA 510(k) clearances (first 1992, latest 2003), across 1 product code in 1 review panel.
How long does FDA take to clear Alphatek Corp.'s 510(k)s?
The median time from FDA receipt to decision across Alphatek Corp.'s cleared 510(k)s is 87 days.
What devices does Alphatek Corp. make?
Its most frequent FDA product codes are IXW (Processor, Radiographic-Film, Automatic, 5).
Has Alphatek Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Alphatek Corp. Related entities may recall under other names.
Next steps
- See all 5 Alphatek Corp. clearances with predicates and recalls
- Run predicate analysis for product code IXW, Alphatek Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.