Alpha Therapeutic Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Alpha Therapeutic Corp.” (first 1981, latest 1997), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| CAK | Microfilter, Blood Transfusion | 3 | 3 |
| BRZ | Set, Blood Transfusion | 1 | 1 |
| KSB | Set, Transfer (Blood/Plasma) | 1 | 1 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | 1 | 1 |
| LDQ | 1 | 1 | |
| MCU | 1 | 1 |
Review panels
- General Hospital (4)
- Hematology (2)
Most recent Alpha Therapeutic Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970225 | ALPHA MICRON 20/40 MICROAGGREGATE FILTER | CAK | 1997-02-14 | 28 |
| K955515 | ALPHA MICRON 20 MICROAGGREGATE FILTER | CAK | 1996-02-12 | 70 |
| K854920 | THERAPY CASSETTS | MCU | 1986-05-19 | 160 |
| K854441 | STUART GILMAN'S WEIGHT LOSS PLAN | LDQ | 1986-02-10 | 97 |
| K833294 | ALPHA Y-RECIPIENT SET | BRZ | 1983-12-27 | 95 |
| K820447 | ALPHA PLASMA TRANSFER SET | KSB | 1982-04-14 | 55 |
| K810897 | ALPHA PLASTIC PLASMA BOTTLE | KSR | 1981-09-23 | 173 |
| K810761 | ALPHA MICRON-40 FILTER | CAK | 1981-06-30 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Alpha Therapeutic Corp..
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 Omega , Ltd. (5 510(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 Therapeutic Corp.?
FDA lists 8 510(k) clearances under the applicant name “Alpha Therapeutic Corp.” (first 1981, latest 1997), across 6 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 Therapeutic Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alpha Therapeutic Corp. is 96 days.
Which FDA product codes appear under Alpha Therapeutic Corp.?
The most frequent FDA product codes under this applicant name are CAK (Microfilter, Blood Transfusion, 3); BRZ (Set, Blood Transfusion, 1); KSB (Set, Transfer (Blood/Plasma), 1).
Next steps
- See all 8 Alpha Therapeutic Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAK, Alpha Therapeutic Corp.'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.