Cosmo Artificial Intelligence - Ai, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cosmo Artificial Intelligence - Ai, Ltd.” (first 2021, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 28 days. Since 2017 the median was 28 days, against 32 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 30 |
| 2022 | 0 | — |
| 2023 | 1 | 28 |
| 2024 | 2 | 28 |
| 2025 | 0 | — |
| 2026 | 1 | 32 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cosmo Artificial Intelligence - Ai, Ltd. took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 32 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QNP | Gastrointesinal Lesion Software Detection System | 6 | 5 |
Review panels
Most recent Cosmo Artificial Intelligence - Ai, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | QNP | 2026-05-29 | 32 |
| K241887 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US) | QNP | 2024-07-25 | 27 |
| K233964 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | QNP | 2024-01-12 | 28 |
| K231143 | GI Genius System 100 and GI Genius System 200 | QNP | 2023-05-19 | 28 |
| K211951 | GI Genius | QNP | 2021-07-23 | 30 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200055 | De Novo | Gastrointesinal Lesion Software Detection System | 2021-04-09 |
Recalls
openFDA lists no recalls under a recalling firm named Cosmo Artificial Intelligence - Ai, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cosmo Far East Technology Limited (2 510(k)s)
- Cosmo Health, Inc. (1 510(k)s)
- Cosmo Technologies, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cosmo Artificial Intelligence - Ai, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Cosmo Artificial Intelligence - Ai, Ltd.” (first 2021, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cosmo Artificial Intelligence - Ai, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cosmo Artificial Intelligence - Ai, Ltd. is 28 days. Since 2017: 28 days, versus 32 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Cosmo Artificial Intelligence - Ai, Ltd.?
The most frequent FDA product codes under this applicant name are QNP (Gastrointesinal Lesion Software Detection System, 6).
Next steps
- See all 5 Cosmo Artificial Intelligence - Ai, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QNP, Cosmo Artificial Intelligence - Ai, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.