De Novo · Granted
GrantedGI 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
Granted on Apr 9, 2021 as a new device type through De Novo after a 213-day review. 22 later devices descend from it.
- Decided
- Apr 9, 2021
- Review
- 213 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
22 later devices descend from it, 5 citing it directly.
- This deviceDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- Descendant · cites it directly · 11 of its ownK211951 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- Descendant · cites it directly · 5 of its ownK213686 SKOUT SoftwareIterative Scopes, Inc. · 2022
- Descendant · 2 generations on · 4 of its ownK231143 GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd. · 2023
- Descendant · 2 generations on · 4 of its ownK230658 SKOUT® systemIterative Scopes, Inc. · 2023
- Descendant · 3 generations on · 3 of its ownK240781 SKOUT® systemIterative Scopes, Inc. · 2024
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K211951GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021 · cites it directly11descendants
- K213686SKOUT SoftwareIterative Scopes, Inc. · 2022 · cites it directly5descendants
- K231143GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd. · 2023 · 2 generations on4descendants
- K230658SKOUT® systemIterative Scopes, Inc. · 2023 · 2 generations on4descendants
- K240781SKOUT® systemIterative Scopes, Inc. · 2024 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| +1 | K211951 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| +1 | K213686 | SKOUT Software | Iterative Scopes, Inc. | 2022 | — |
| +2 | K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. | 2023 | — |
| +2 | K230658 | SKOUT® system | Iterative Scopes, Inc. | 2023 | — |
| +3 | K240781 | SKOUT® system | Iterative Scopes, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (22)
See all 225 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?
- Of its descendants, K211951 (Cosmo Artificial Intelligence - Ai, Ltd., 2021) has gone furthest, with 11 descendants 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. 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/DEN200055 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200055: GI Genius.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200055
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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