Equidyne Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Equidyne Systems, Inc.” (first 1995, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| KZE | Injector, Fluid, Non-Electrically Powered | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Equidyne Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022502 | INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 | KZE | 2002-09-05 | 38 |
| K022148 | INJEX 30 NEEDLE FREE INJECTION SYSTEM | KZE | 2002-07-23 | 21 |
| K003741 | JET SYRINGE MODEL-100500 | KZE | 2001-06-01 | 179 |
| K003864 | INJEX 50 SYSTEM | KZE | 2001-03-06 | 83 |
| K945873 | HYPEX(TM) JET INJECTOR | KZE | 1995-08-18 | 260 |
Recalls
openFDA lists no recalls under a recalling firm named Equidyne Systems, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Equidyne Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Equidyne Systems, Inc.” (first 1995, latest 2002), 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 Equidyne Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Equidyne Systems, Inc. is 83 days.
Which FDA product codes appear under Equidyne Systems, Inc.?
The most frequent FDA product codes under this applicant name are KZE (Injector, Fluid, Non-Electrically Powered, 5).
Next steps
- See all 5 Equidyne Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KZE, Equidyne Systems, 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.