Texas Medical Products, Inc.: FDA clearances and approvals
Texas Medical Products, Inc. has 30 FDA 510(k) clearances (first 1980, latest 1989), across 16 product codes in 3 review panels. Median 510(k) review time: 17 days.
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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 8 | 8 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 5 | 5 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 3 | 3 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 1 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | 1 | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| FNY | Basin, Emesis | 1 | 1 |
Plus 6 more product codes.
Review panels
Most recent Texas Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893417 | SURGIFRESH SUB-MICRON MASK NO. 901008-000 | FXX | 1989-06-22 | 51 |
| K870932 | SURGIFRESH SURGICAL SMOKE REMOVAL | — | 1987-03-31 | 22 |
| K851575 | DR. BRUNO LNAGE MINI PHOTOMETER | — | 1985-10-18 | 184 |
| K830634 | CARDIOTOMY FILTER | JOD | 1983-06-30 | 121 |
| K813587 | DISPOSABLE THORACIC CATHETER | GBS | 1982-01-12 | 15 |
| K810532 | DISPOSABLE STOPCOCK | DTZ | 1981-04-23 | 56 |
| K810515 | DISPOSABLE 2-STAGE CANNULA | DWF | 1981-04-23 | 57 |
| K810395 | PRE-BYPASS FILTER | KRJ | 1981-03-05 | 15 |
| K802545 | CARDIOPLEGIC SETS | DTR | 1981-01-16 | 93 |
| K802544 | DISPOSABLE QUICK RELEASE PERFUSION ADAP | DTL | 1981-01-16 | 93 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Texas Medical Products, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Texas Medical Products, Inc. have?
Texas Medical Products, Inc. has 30 FDA 510(k) clearances (first 1980, latest 1989), across 16 product codes in 3 review panels.
How long does FDA take to clear Texas Medical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Texas Medical Products, Inc.'s cleared 510(k)s is 17 days.
What devices does Texas Medical Products, Inc. make?
Its most frequent FDA product codes are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 8); DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, 5); KRI (Accessory Equipment, Cardiopulmonary Bypass, 3).
Has Texas Medical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Texas Medical Products, Inc. Related entities may recall under other names.
Next steps
- See all 30 Texas Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWF, Texas Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.