Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Augmedics, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
255 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261854 | xvision Spine system | Augmedics, Ltd. | 2026-07-31 | 58 | 0 |
| K251639 | xvision Spine system | Augmedics, Ltd. | 2025-10-03 | 127 | 0 |
| K250255 | xvision Spine system | Augmedics, Ltd. | 2025-03-13 | 44 | 0 |
| K241481 | xvision Spine System | Augmedics, Ltd. | 2024-10-16 | 145 | 0 |
| K220905 | xvision Spine System | Augmedics, Ltd. | 2022-11-17 | 234 | 0 |
| K211188 | xvision Spine system (XVS) | Augmedics, Ltd. | 2021-07-19 | 90 | 1 |
| K190929 | xvision Spine system (XVS) | Augmedics, Ltd. | 2019-12-20 | 255 | 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