Med-Tec,Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Med-Tec,Inc.” (first 1998, latest 2004), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 120 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 3 | 3 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 2 | 2 |
| JAI | Couch, Radiation Therapy, Powered | 2 | 2 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
Review panels
- Radiology (8)
Most recent Med-Tec,Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K034054 | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 | JAI | 2004-02-20 | 52 |
| K031866 | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC | JAI | 2003-08-14 | 59 |
| K021360 | SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 | KXK | 2003-06-10 | 406 |
| K023293 | MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 | IYE | 2002-12-23 | 82 |
| K013875 | MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE | IXI | 2002-09-27 | 308 |
| K001052 | MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX | IYE | 2000-08-30 | 149 |
| K981992 | ELECTRON WEDGE MODEL MT-EW-1000 | IXI | 1998-12-15 | 190 |
| K982624 | MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 | IYE | 1998-10-26 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Med-Tec,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.
- Med-Tec, Inc. D/B/A Civco Medical Solutions (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Med-Tec,Inc.?
FDA lists 8 510(k) clearances under the applicant name “Med-Tec,Inc.” (first 1998, latest 2004), across 4 product codes 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 Med-Tec,Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Med-Tec,Inc. is 120 days.
Which FDA product codes appear under Med-Tec,Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 3); IXI (Block, Beam-Shaping, Radiation Therapy, 2); JAI (Couch, Radiation Therapy, Powered, 2).
Next steps
- See all 8 Med-Tec,Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Med-Tec,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.