Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QZZ · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253066 | ELEOS™ with NanoCept® Technology Limb Salvage System | Onkos Surgical, Inc. | 2026-06-08 | 259 | 0 |
| K252920 | ELEOS™ Limb Salvage System with NanoCept® Technology | Onkos Surgical, Inc. | 2025-10-15 | 33 | 0 |
| DEN210058 | ELEOSx™ Limb Salvage System | Onkos Surgical | 2024-04-05 | 827 | 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