510(k) · Cleared
ClearedGI Genius
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 Jul 23, 2021 as substantially equivalent to DEN200055 (Cosmo Artificial Intelligence - Ai, Ltd., 2021) after a 30-day review. Its family tree reaches back 1 generation to 2021. 11 later devices descend from it.
- Decided
- Jul 23, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200055 (2021). 11 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- This deviceK211951 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK231143 GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK233964 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200…Cosmo Artificial Intelligence - Ai, Ltd. · 2024
- Descendant · cites it directly · 3 of its ownK223473 ME-Apds™; Magentiq-Colo™Magentiq Eye, Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK244023 Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd. · 2025
- Descendant · 3 generations on · 1 of its ownK252178 Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K231143GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd. · 2023 · cites it directly4descendants
- K233964GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0…Cosmo Artificial Intelligence - Ai, Ltd. · 2024 · 2 generations on3descendants
- K223473ME-Apds™; Magentiq-Colo™Magentiq Eye, Ltd. · 2023 · cites it directly3descendants
- K244023Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd. · 2025 · 2 generations on2descendants
- K252178Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| 0 (this device) | 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 | — |
| +2 | K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US)… | Cosmo Artificial Intelligence - Ai, Ltd. | 2024 | — |
| +1 | K223473 | ME-Apds™; Magentiq-Colo™ | Magentiq Eye, Ltd. | 2023 | — |
| +2 | K244023 | Magentiq-Colo (ME-Apds) | Magentiq Eye, Ltd. | 2025 | — |
| +3 | K252178 | Magentiq-Colo (ME-Apds) | Magentiq Eye, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | DEN200055 | GI GeniusSummary page 5…Page 2 of 4 The indications for use statement is identical to that for the original unmodified (predicate) device, as cleared under DEN200055. Device Description: GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images co… | 2021 |
What descends from it? (11)
See all 113 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?
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. 2021, 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/K211951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211951: GI Genius.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211951
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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