Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
PIB — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
199 daysmedian FDA review time
269 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253704 | iPredict-DR | iHealthscreen, Inc. | 2026-07-02 | 220 | 0 |
| K240058 | AEYE-DS | Aeye Health, Inc. | 2024-04-23 | 106 | 0 |
| K223357 | EyeArt v2.2.0 | Eyenuk, Inc. | 2023-06-16 | 226 | 0 |
| K221183 | AEYE-DS | Aeye Health, Inc. | 2022-11-10 | 199 | 0 |
| K213037 | IDx-DR v2.3 | Digital Diagnostics, Inc. | 2022-06-17 | 269 | 0 |
| K203629 | IDx-DR | Digital Diagnostics, Inc. | 2021-06-10 | 181 | 0 |
| K200667 | EyeArt | Eyenuk, Inc. | 2020-08-03 | 143 | 0 |
| DEN180001 | IDx-DR | Idx, LLC | 2018-04-11 | 89 | 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