Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
SDD — 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) |
|---|---|---|---|---|---|
| K260653 | Dexter L6 System | Distalmotion SA | 2026-06-11 | 104 | 0 |
| K251197 | Dexter L6 System | Distalmotion SA | 2025-09-30 | 166 | 0 |
| K250435 | Dexter L6 System | Distalmotion SA | 2025-05-27 | 102 | 0 |
| DEN230084 | Dexter L6 System | Distalmotion SA | 2024-10-25 | 315 | 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