Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Texasmedical Technologies, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
230 daysmedian FDA review time
258 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170915 | TXM Hydrophilic Guidewire | Texasmedical Technologies, Inc. | 2017-11-21 | 238 | 0 |
| K170914 | TXM Support Catheter | Texasmedical Technologies, Inc. | 2017-11-21 | 238 | 0 |
| K153771 | TXM Guiding Sheath | Texasmedical Technologies, Inc. | 2016-09-13 | 258 | 0 |
| K153703 | Guiding Catheter | Texasmedical Technologies, Inc. | 2016-05-12 | 141 | 0 |
| K153125 | IntraNovo Microcatheter | Texasmedical Technologies, Inc. | 2016-01-13 | 76 | 0 |
| K142954 | PTA 14 Balloon Dilatation Catheter OTW | Texasmedical Technologies, Inc. | 2015-05-28 | 230 | 0 |
| K142817 | IntraNovo 25 Microcatheter | Texasmedical Technologies, Inc. | 2015-04-23 | 206 | 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