Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thermotek, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103247 | VASCUCOMP | Thermotek, Inc. | 2010-12-10 | 37 | 0 |
| K061866 | NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS | Thermotek, Inc. | 2006-08-22 | 50 | 0 |
| K945853 | THERMOTEK H-300 | Thermotek, Inc. | 1995-10-05 | 339 | 0 |
| K950711 | T-350 THERAPEUTIC COOLING MACHINE | Thermotek, Inc. | 1995-07-06 | 142 | 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