Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QRY · 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) |
|---|---|---|---|---|---|
| K232148 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2024-02-21 | 217 | 2 |
| K222750 | Yomi Robotic System | Neocis, Inc. | 2022-12-08 | 87 | 0 |
| K222049 | Yomi Robotic System | Neocis, Inc. | 2022-11-04 | 115 | 0 |
| K211701 | X-Guide® Surgical Navigation System | X-Nav Technologies, LLC | 2022-02-01 | 243 | 1 |
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