Biodex Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Biodex Corp.” (first 1986, latest 1992), across 1 product code in 1 review panel. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | 7 | 7 |
Review panels
Most recent Biodex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915846 | BIODEX SYSTEM 2 AUTOPROGRAM | IKK | 1992-01-13 | 31 |
| K915648 | BIODEX SYSTEM 2 AUTOPROGRAM | IKK | 1992-01-09 | 27 |
| K913021 | BIODEX,MODEL B-2000 | IKK | 1991-10-03 | 86 |
| K913020 | BIODEX SYSTEM 2,MODEL S2-S | IKK | 1991-10-03 | 86 |
| K900450 | BIODEX LIFT SIMULATOR | IKK | 1990-07-24 | 175 |
| K900741 | BIODEX BACK SYSTEM ATTACHMENT | IKK | 1990-02-26 | 10 |
| K860821 | BIODEX SYSTEM | IKK | 1986-04-18 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Biodex 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.
- Biodex Medical Systems, Inc. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biodex Corp.?
FDA lists 7 510(k) clearances under the applicant name “Biodex Corp.” (first 1986, latest 1992), 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 Biodex Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biodex Corp. is 45 days.
Which FDA product codes appear under Biodex Corp.?
The most frequent FDA product codes under this applicant name are IKK (System, Isokinetic Testing And Evaluation, 7).
Next steps
- See all 7 Biodex Corp. clearances with predicates and recalls
- Run predicate analysis for product code IKK, Biodex 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.