Alphamedix, Inc.: FDA clearances and approvals
Alphamedix, Inc. has 7 FDA 510(k) clearances (first 1982, latest 1985), across 5 product codes in 3 review panels. Median 510(k) review time: 85 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 |
|---|---|---|---|
| HNN | Knife, Ophthalmic | 2 | 2 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 | 2 |
| FYA | Gown, Surgical | 1 | 1 |
| FZZ | Marker, Skin | 1 | 1 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
Review panels
Most recent Alphamedix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852706 | VERSABLADE | HNN | 1985-11-04 | 131 |
| K852633 | VERSABLADE | HNN | 1985-11-04 | 137 |
| K851272 | VERSAPHAGE | HQE | 1985-07-05 | 95 |
| K830812 | ALPHAMEDIX I/A HAND-PIECE, 500-001 | HQC | 1983-06-08 | 85 |
| K830703 | GLOMARK | FZZ | 1983-04-28 | 52 |
| K820363 | DISPOSABLE SURGICAL GARMENTS | FYA | 1982-03-08 | 27 |
| K820008 | VERSATOME I | HQE | 1982-02-22 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Alphamedix, Inc..
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 Alphamedix, Inc. have?
Alphamedix, Inc. has 7 FDA 510(k) clearances (first 1982, latest 1985), across 5 product codes in 3 review panels.
How long does FDA take to clear Alphamedix, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Alphamedix, Inc.'s cleared 510(k)s is 85 days.
What devices does Alphamedix, Inc. make?
Its most frequent FDA product codes are HNN (Knife, Ophthalmic, 2); HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 2); FYA (Gown, Surgical, 1).
Has Alphamedix, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Alphamedix, Inc. Related entities may recall under other names.
Next steps
- See all 7 Alphamedix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HNN, Alphamedix, Inc.'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.