Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QPP · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234056 | canturio® se (Canturio Smart Extension) | Canary Medical USA, LLC | 2024-04-24 | 124 | 1 |
| K223803 | Canary Tibial Extension (CTE) with Canary Health Implanted R | Canary Medical USA, LLC | 2023-03-24 | 95 | 0 |
| K220413 | Canary Tibial Extension (CTE) with Canary Health Implanted R | Canary Medical USA, LLC | 2022-06-22 | 128 | 0 |
| DEN200064 | Canary Tibial Extension with Canary Health Implanted Reporti | Canary Medical, Inc. | 2021-08-27 | 312 | 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