Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Texas Medical Products, Inc. · Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
17 daysmedian FDA review time
93 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893417 | SURGIFRESH SUB-MICRON MASK NO. 901008-000 | Texas Medical Products, Inc. | 1989-06-22 | 51 | 0 |
| K870932 | SURGIFRESH SURGICAL SMOKE REMOVAL | Texas Medical Products, Inc. | 1987-03-31 | 22 | 0 |
| K851575 | DR. BRUNO LNAGE MINI PHOTOMETER | Texas Medical Products, Inc. | 1985-10-18 | 184 | 0 |
| K830634 | CARDIOTOMY FILTER | Texas Medical Products, Inc. | 1983-06-30 | 121 | 0 |
| K813587 | DISPOSABLE THORACIC CATHETER | Texas Medical Products, Inc. | 1982-01-12 | 15 | 0 |
| K810515 | DISPOSABLE 2-STAGE CANNULA | Texas Medical Products, Inc. | 1981-04-23 | 57 | 0 |
| K810532 | DISPOSABLE STOPCOCK | Texas Medical Products, Inc. | 1981-04-23 | 56 | 0 |
| K810395 | PRE-BYPASS FILTER | Texas Medical Products, Inc. | 1981-03-05 | 15 | 0 |
| K802539 | DISPOSABLE GAS LINE FILTER | Texas Medical Products, Inc. | 1981-01-16 | 93 | 0 |
| K802541 | DISPOSABLE PARALLEL Y CONNECTORS | Texas Medical Products, Inc. | 1981-01-16 | 93 | 0 |
| K802542 | DISPOSABLE CONNECTORS | Texas Medical Products, Inc. | 1981-01-16 | 93 | 0 |
| K802543 | RIDGID VENA CAVA CANNULAE | Texas Medical Products, Inc. | 1981-01-16 | 93 | 0 |
| K802544 | DISPOSABLE QUICK RELEASE PERFUSION ADAP | Texas Medical Products, Inc. | 1981-01-16 | 93 | 0 |
| K802545 | CARDIOPLEGIC SETS | Texas Medical Products, Inc. | 1981-01-16 | 93 | 0 |
| K802537 | DISPOSABLE SURGICAL DRAPE | Texas Medical Products, Inc. | 1980-11-12 | 28 | 0 |
| K802538 | BASIN PACK | Texas Medical Products, Inc. | 1980-10-31 | 16 | 0 |
| K801392 | DISPOSABLE SUMP SETS | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K801393 | AIR ASPIRATOR NEEDLE | Texas Medical Products, Inc. | 1980-06-30 | 17 | 1 |
| K801394 | CARDIOPULMONARY BYPASS PUMP TUBING | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K801395 | VASCULAR CLAMP | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K801396 | SAPHENOUS VEIN CANNULAE | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K801397 | VENA CAVA CANNULAE | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K801398 | AORTIC AND FEMORAL PERFUSION CANNULAE | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K801399 | CORONARY PERFUSION CONNECTOR PLUG | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K801400 | DISPOSABLE SUCKER SYSTEM | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K801401 | CARDIOPULMONARY BYPASS TUBING | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K801402 | QUICKIE PRIME CARDIOP. BYPASS PERF. INTR | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K801403 | DISPOSABLE PERFUSION SET | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
| K801404 | DISPOSABLE PARALLEL Y CONNECTORS | Texas Medical Products, Inc. | 1980-06-30 | 17 | 1 |
| K801405 | DISPOSABLE PERFUSION CONNECTORS | Texas Medical Products, Inc. | 1980-06-30 | 17 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda