Biodex Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Biodex Medical Systems, Inc.” (first 1994, latest 2009), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 276 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 |
|---|---|---|---|
| BXB | Exerciser, Powered | 3 | 3 |
| IKK | System, Isokinetic Testing And Evaluation | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
| KHX | Platform, Force-Measuring | 1 | 1 |
| KPT | Calibrator, Dose, Radionuclide | 1 | 1 |
| MMK | Container, Sharps | 1 | 1 |
Review panels
- Physical Medicine (6)
- Radiology (2)
- General Hospital (1)
Most recent Biodex Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090296 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 | KPT | 2009-02-19 | 13 |
| K063666 | SHARPS CONTAINER, MODEL 039-413 | MMK | 2007-01-25 | 45 |
| K951770 | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP | IKK | 1995-11-16 | 213 |
| K950981 | ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 | IXR | 1995-04-03 | 31 |
| K942694 | STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 | KHX | 1995-03-10 | 276 |
| K940301 | COMPEX 2 | IPF | 1994-12-28 | 338 |
| K935520 | UPPER BODY CYCLES (110 VOLT)/(220 VOLT) | BXB | 1994-09-16 | 302 |
| K935216 | SEMI-RECUMBENT CYCLES | BXB | 1994-09-16 | 325 |
| K935061 | LOWER BODY CYCLES | BXB | 1994-09-16 | 330 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-08-16.
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 Corp. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biodex Medical Systems, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Biodex Medical Systems, Inc.” (first 1994, latest 2009), across 7 product codes in 3 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 Biodex Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biodex Medical Systems, Inc. is 276 days.
Which FDA product codes appear under Biodex Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are BXB (Exerciser, Powered, 3); IKK (System, Isokinetic Testing And Evaluation, 1); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 9 Biodex Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BXB, Biodex Medical 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.