510(k) · Cleared
ClearedGI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosmo Artificial Intelligence - Ai, Ltd. · QNP Gastrointesinal Lesion Software Detection System
Cleared on Jan 12, 2024 as substantially equivalent to K231143 (Cosmo Artificial Intelligence - Ai, Ltd., 2023) after a 28-day review. Its family tree reaches back 3 generations to 2021. 3 later devices descend from it.
- Decided
- Jan 12, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN200055 (2021). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- 2 generations backK211951 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- 1 generation backK231143 GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd. · 2023
- This deviceK233964 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200…Cosmo Artificial Intelligence - Ai, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK241887 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200…Cosmo Artificial Intelligence - Ai, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK252853 CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK261369 GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd. · 2026
Most influential descendants
Showing 3 of 3 · See all- K241887GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0…Cosmo Artificial Intelligence - Ai, Ltd. · 2024 · cites it directly1descendant
- K252853CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
- K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| −2 | K211951 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| −1 | K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. | 2023 | — |
| 0 (this device) | K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US)… | Cosmo Artificial Intelligence - Ai, Ltd. | 2024 | — |
| +1 | K241887 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US)… | Cosmo Artificial Intelligence - Ai, Ltd. | 2024 | — |
| +1 | K252853 | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | 2026 | — |
| +2 | K261369 | GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QNP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QNP device
- #1 K252178 Magentiq-Colo (ME-Apds)score 14.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231143 | GI Genius System 100 and GI Genius System 200Summary page 6…ended to replace clinical decision making. The indications for use statement is the same as that of the original unmodified (predicate) device, as cleared under K231143. Device Description: GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy i… | 2023 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K241887 (Cosmo Artificial Intelligence - Ai, Ltd., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QNP devicesQNP Gastrointesinal Lesion Software Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QNP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QNP
28in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QNP
No recall names QNP since 2007.
Adverse event reports per year · QNP
1in 2024
MAUDE reports naming product code QNP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 3 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 4 | 140 | 0 | 0 |
| 2024 | 5 | 29 | 0 | 1 |
| 2025 | 5 | 28 | 0 | 0 |
| 2026 | 5 | 169 | 0 | — |
What is it indicated for?
The GI Genius™ system is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius™ computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233964: GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233964
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026