Medtec, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Medtec, Inc.” (first 1993, latest 2014), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 92 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 | 1 | 168 |
| 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 | 20 | 20 |
| IWE | Monitor, Patient Position, Light-Beam | 7 | 7 |
| IWS | Shield, Eye, Radiological | 2 | 2 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 2 | 2 |
| IXQ | Table, Radiographic, Stationary Top | 2 | 2 |
| KPY | Shield, Protective, Personnel | 2 | 2 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 2 |
| IXA | Cassette, Radiographic Film | 1 | 1 |
| JAD | System, Therapeutic, X-Ray | 1 | 1 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (40)
- Clinical Chemistry (1)
Most recent Medtec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132908 | TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT | IYE | 2014-03-04 | 168 |
| K111340 | HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM | LNH | 2011-06-28 | 47 |
| K093738 | MRI PATIENT POSITIONING DEVICES | LNH | 2010-05-14 | 161 |
| K974703 | CARBON FIBER BREAST BOARD | IYE | 1998-03-10 | 84 |
| K974700 | MATRIX MT-MX3 | IYE | 1998-03-04 | 78 |
| K973842 | CARBON FIBER CONFORMAL COUCH TOP | IXQ | 1997-12-05 | 58 |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | KPY | 1996-10-01 | 88 |
| K955236 | GREEN TEC-2100 | IWE | 1996-05-24 | 192 |
| K954705 | ACRYSTEEL BLOCKING TRAY | IYE | 1996-01-05 | 85 |
| K954456 | THERMOPLASTIC SHIELD | KPY | 1995-12-21 | 87 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medtec, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medtec, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
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.
- Medtec Inc. Dba Civco Medical Solutions (2 510(k)s)
- Medtec, Inc. D/B/A Civco Medical Solutions (1 510(k)s)
- Medtec, Inc. Dba Civco Medical Solutions and Civco (1 510(k)s)
- Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtec, Inc.?
FDA lists 41 510(k) clearances under the applicant name “Medtec, Inc.” (first 1993, latest 2014), across 11 product codes in 2 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 Medtec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtec, Inc. is 92 days.
Which FDA product codes appear under Medtec, Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 20); IWE (Monitor, Patient Position, Light-Beam, 7); IWS (Shield, Eye, Radiological, 2).
Next steps
- See all 41 Medtec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Medtec, 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 (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.