Argosy Electronics: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Argosy Electronics” (first 1993, latest 1998), across 1 product code in 1 review panel. Median 510(k) review time under this name: 28 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 | 24 | 24 |
Review panels
- Ear, Nose and Throat (24)
Most recent Argosy Electronics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974242 | ARGOSY PROGRAMMABLE ONQUE | ESD | 1998-01-20 | 69 |
| K971699 | ARGOSY DYNAMEQ | ESD | 1997-07-03 | 56 |
| K961729 | ARGOSY PROGRAMMABLE | ESD | 1996-05-29 | 26 |
| K954038 | K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT | ESD | 1995-09-18 | 21 |
| K952452 | OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL | ESD | 1995-07-06 | 42 |
| K952451 | CLASS D LINEAR WITH ACTIVE TONE CONTROL | ESD | 1995-07-06 | 42 |
| K952450 | WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL | ESD | 1995-07-06 | 42 |
| K952455 | IMPROVED MANHATTAN II | ESD | 1995-06-21 | 27 |
| K952454 | EXPANDER WITH ACTIVE TONE CONTROL | ESD | 1995-06-21 | 27 |
| K952453 | INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL | ESD | 1995-06-21 | 27 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Argosy Electronics.
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 Intl. (Usa), Inc. (14 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Argosy Electronics?
FDA lists 24 510(k) clearances under the applicant name “Argosy Electronics” (first 1993, latest 1998), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Argosy Electronics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Argosy Electronics is 28 days.
Which FDA product codes appear under Argosy Electronics?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 24).
Next steps
- See all 24 Argosy Electronics clearances with predicates and recalls
- Run predicate analysis for product code ESD, Argosy Electronics'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.