Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Uvision360, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210512 | LUMINELLE DTx System | Uvision360, Inc. | 2021-06-30 | 127 | 0 |
| K192278 | Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatabl | Uvision360, Inc. | 2019-11-01 | 71 | 0 |
| K190827 | Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable S | Uvision360, Inc. | 2019-06-06 | 66 | 0 |
| K181909 | Luminelle DTx Hysteroscopy System | Uvision360, Inc. | 2018-08-16 | 30 | 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