Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QNP · Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
32 daysmedian FDA review time
263 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260567 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2026-08-07 | 169 | 0 |
| K252853 | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | 2026-08-05 | 331 | 0 |
| K261369 | GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | 2026-05-29 | 32 | 0 |
| K260724 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2026-04-03 | 29 | 0 |
| K253664 | SKOUT system | Iterative Health | 2025-12-22 | 32 | 0 |
| K252178 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2025-10-03 | 84 | 0 |
| K252586 | CADDIE | Odin Medical Limited | 2025-09-12 | 28 | 0 |
| K251126 | SKOUT system | Iterative Health | 2025-05-09 | 28 | 0 |
| K244023 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2025-01-24 | 28 | 0 |
| K241887 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GG | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-07-25 | 27 | 0 |
| K240044 | CADDIE | Odin Medical Limited | 2024-07-24 | 201 | 0 |
| K241508 | SKOUT® system | Iterative Scopes, Inc. | 2024-07-03 | 36 | 0 |
| K240781 | SKOUT® system | Iterative Scopes, Inc. | 2024-04-19 | 29 | 0 |
| K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GG | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-01-12 | 28 | 0 |
| K230751 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2023-12-15 | 273 | 0 |
| K223473 | ME-APDS™; MAGENTIQ-COLO™ | Magentiq Eye, Ltd. | 2023-07-25 | 250 | 0 |
| K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. | 2023-05-19 | 28 | 0 |
| K230658 | SKOUT® system | Iterative Scopes, Inc. | 2023-04-07 | 29 | 0 |
| K213686 | SKOUT Software | Iterative Scopes, Inc. | 2022-08-12 | 263 | 0 |
| K211326 | EndoScreener | Chengdu Wision Medical Device Co., Ltd. | 2021-11-19 | 203 | 0 |
| K211951 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021-07-23 | 30 | 0 |
| DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021-04-09 | 213 | 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