Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cosmo Artificial Intelligence - Ai, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
213 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261369 | GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | 2026-05-29 | 32 | 0 |
| K241887 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GG | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-07-25 | 27 | 0 |
| K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GG | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-01-12 | 28 | 0 |
| K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. | 2023-05-19 | 28 | 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