Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QQU — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
149 daysmedian FDA review time
261 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243819 | Luminopia | Luminopia, Inc. | 2025-04-09 | 118 | 0 |
| K233720 | Luminopia | Luminopia, Inc. | 2024-08-08 | 261 | 0 |
| K221659 | Luminopia One | Luminopia, Inc. | 2022-11-04 | 149 | 0 |
| K221375 | CureSight-CS100 | Novasight , Ltd. | 2022-09-29 | 140 | 0 |
| DEN210005 | Luminopia One | Luminopia, Inc. | 2021-10-20 | 233 | 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