Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thermopeutix, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
252 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132701 | PRIMI SUPPORT CATHETER | Thermopeutix, Inc. | 2013-09-26 | 28 | 0 |
| K130850 | PRIMI AND SECONDI SUPPORT CATHETERS | Thermopeutix, Inc. | 2013-06-25 | 90 | 0 |
| K112219 | TAPAS CATHETER | Thermopeutix, Inc. | 2011-11-18 | 108 | 0 |
| K093847 | DUFLO CATHETER (HEPARIN COATED) | Thermopeutix, Inc. | 2010-08-25 | 252 | 0 |
| K080700 | DUOFLO CATHETER | Thermopeutix, Inc. | 2008-09-26 | 199 | 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