Argosy Intl. (Usa), Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Argosy Intl. (Usa), Inc.” (first 1978, latest 1982), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 9 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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 12 | 12 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ear, Nose and Throat (12)
- Orthopedic (1)
Most recent Argosy Intl. (Usa), Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823075 | REXTON | — | 1982-11-08 | 20 |
| K791548 | REXTON HS(HEARING SYSTEM) | HSD | 1979-09-28 | 46 |
| K781096 | HEARING AID, EYEGLASS, B-12 | ESD | 1978-07-17 | 17 |
| K781095 | HEARING AID, BEHIND THE EAR | ESD | 1978-07-17 | 17 |
| K781094 | HEARING AID, EYEGLASS | ESD | 1978-07-17 | 17 |
| K780922 | UM VII (BEHIND THE EAR) | ESD | 1978-06-14 | 9 |
| K780921 | MM-CE DM (BEHIND THE EAR) | ESD | 1978-06-14 | 9 |
| K780920 | MM-CE 11 (BEHIND THE EAR) | ESD | 1978-06-14 | 9 |
| K780919 | M25 PP (BEHIND THE EAR) | ESD | 1978-06-14 | 9 |
| K780918 | PRIMO CEDM (BEHIND THE EAR) | ESD | 1978-06-14 | 9 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Argosy Intl. (Usa), 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.
- Argosy Electronics (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Argosy Intl. (Usa), Inc.?
FDA lists 14 510(k) clearances under the applicant name “Argosy Intl. (Usa), Inc.” (first 1978, latest 1982), across 3 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 Argosy Intl. (Usa), Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Argosy Intl. (Usa), Inc. is 9 days.
Which FDA product codes appear under Argosy Intl. (Usa), Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 12); HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, 1).
Next steps
- See all 14 Argosy Intl. (Usa), Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Argosy Intl. (Usa), 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.