Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tenacore Holdings, 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) |
|---|---|---|---|---|---|
| K081335 | TENACORE OXYGEN BLENDER, MODEL TB-2000 | Tenacore Holdings, Inc. | 2008-11-14 | 186 | 0 |
| K053420 | TENACORE SP02 SENSORS | Tenacore Holdings, Inc. | 2006-11-15 | 342 | 0 |
| K043075 | TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETE | Tenacore Holdings, Inc. | 2005-08-18 | 283 | 0 |
| K012041 | THE HAMMER MODEL H100 | Tenacore Holdings, Inc. | 2002-03-28 | 272 | 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