Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Luma Vision Limited · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | 2026-07-24 | 51 | 0 |
| K260885 | VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited | 2026-06-15 | 90 | 0 |
| K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging | Luma Vision Limited | 2025-03-24 | 182 | 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