Texasmedical Technologies, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Texasmedical Technologies, Inc.” (first 2015, latest 2017), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 230 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 |
|---|---|---|
| 2015 | 2 | 218 |
| 2016 | 3 | 141 |
| 2017 | 2 | 238 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Texasmedical Technologies, Inc. took a median 238 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Texasmedical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170915 | TXM Hydrophilic Guidewire | DQX | 2017-11-21 | 238 |
| K170914 | TXM Support Catheter | DQY | 2017-11-21 | 238 |
| K153771 | TXM Guiding Sheath | DYB | 2016-09-13 | 258 |
| K153703 | Guiding Catheter | DQY | 2016-05-12 | 141 |
| K153125 | IntraNovo Microcatheter | DQO | 2016-01-13 | 76 |
| K142954 | PTA 14 Balloon Dilatation Catheter OTW | LIT | 2015-05-28 | 230 |
| K142817 | IntraNovo 25 Microcatheter | DQO | 2015-04-23 | 206 |
Recalls
openFDA lists no recalls under a recalling firm named Texasmedical Technologies, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Texasmedical Technologies, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Texasmedical Technologies, Inc.” (first 2015, latest 2017), across 5 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 Texasmedical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Texasmedical Technologies, Inc. is 230 days.
Which FDA product codes appear under Texasmedical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 2); DQY (Catheter, Percutaneous, 2); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 7 Texasmedical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQO, Texasmedical Technologies, 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.