Alpha Unlimited, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Alpha Unlimited, Inc.” (first 1984, latest 1989), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 4 | 4 |
| ITI | Wheelchair, Powered | 3 | 3 |
| HFW | Clamp, Umbilical | 1 | 1 |
| INM | Chair, With Casters | 1 | 1 |
| IPL | Wheelchair, Standup | 1 | 1 |
Review panels
Most recent Alpha Unlimited, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K894646 | #556 DISPOSABLE UMBILICAL CORD CLAMP (2) | HFW | 1989-09-05 | 43 |
| K893429 | ALPHA CONDOR | INI | 1989-06-12 | 41 |
| K893428 | ALPHA SHOPPER | ITI | 1989-06-12 | 41 |
| K893248 | ALPHA MALLARD | INI | 1989-05-26 | 28 |
| K853766 | ALPHA SUPER KART | INI | 1985-11-20 | 72 |
| K841921 | ALPHA PLUS 1 | ITI | 1984-05-23 | 13 |
| K841920 | MAC-MULTI-ADJUSTABLE CHAIR | IPL | 1984-05-23 | 13 |
| K841919 | ALPHA TRI-KART | INI | 1984-05-23 | 13 |
| K841912 | ALPHA 4 X 4 | ITI | 1984-05-23 | 14 |
| K841911 | ALPHA PUSH KART | INM | 1984-05-23 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Alpha Unlimited, Inc..
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 Omega Engineering , Ltd. (9 510(k)s)
- Alpha Therapeutic Corp. (8 510(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 Unlimited, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Alpha Unlimited, Inc.” (first 1984, latest 1989), across 5 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 Unlimited, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alpha Unlimited, Inc. is 21 days.
Which FDA product codes appear under Alpha Unlimited, Inc.?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 4); ITI (Wheelchair, Powered, 3); HFW (Clamp, Umbilical, 1).
Next steps
- See all 10 Alpha Unlimited, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INI, Alpha Unlimited, 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.