Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thera Kinetics, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912537 | JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION | Thera Kinetics, Inc. | 1991-08-16 | 67 | 0 |
| K913227 | JACE MODEL T300 TOE CPM DEVICE | Thera Kinetics, Inc. | 1991-08-16 | 25 | 0 |
| K903467 | JACE MODEL 100 KNEE CPM DEVICE | Thera Kinetics, Inc. | 1990-08-10 | 9 | 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