Dantec Medical, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Dantec Medical, Inc.” (first 1990, latest 1996), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 211 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 |
|---|---|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 6 | 6 |
| GWF | Stimulator, Electrical, Evoked Response | 5 | 5 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| EXY | Uroflowmeter | 1 | 1 |
| FEN | Device, Cystometric, Hydraulic | 1 | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| GXE | Leukotome | 1 | 1 |
Plus 3 more product codes.
Review panels
- Neurology (13)
- Gastroenterology and Urology (8)
- Radiology (3)
- General Hospital (1)
Most recent Dantec Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960503 | DANTEC DUET | FEN | 1996-09-16 | 227 |
| K950314 | DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) | GXZ | 1996-03-25 | 424 |
| K953999 | DANTEC DA CAPO | EXY | 1995-11-21 | 89 |
| K926363 | MULTI-DOP S | IYO | 1995-06-19 | 910 |
| K931801 | MULTI-DOP X | IYO | 1995-06-14 | 867 |
| K930458 | MULTI-DOP L | IYN | 1995-02-03 | 736 |
| K932059 | NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE | IKT | 1994-10-04 | 523 |
| K934580 | DANTEC 13R45 BAR ELECTRODE | GXY | 1994-09-26 | 368 |
| K931966 | DANTEC DISPOSABLE CONCENTRIC NEEDLE | IKT | 1994-03-30 | 343 |
| K931923 | DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) | GWF | 1993-11-09 | 207 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dantec Medical, 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.
- Dantec Electronics, Inc. (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dantec Medical, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Dantec Medical, Inc.” (first 1990, latest 1996), across 13 product codes in 4 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 Dantec Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dantec Medical, Inc. is 211 days.
Which FDA product codes appear under Dantec Medical, Inc.?
The most frequent FDA product codes under this applicant name are FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 6); GWF (Stimulator, Electrical, Evoked Response, 5); IKT (Electrode, Needle, Diagnostic Electromyograph, 3).
Next steps
- See all 25 Dantec Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FAP, Dantec Medical, 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.