510(k) · Cleared
ClearedCaddie
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Odin Medical Limited · QNP Gastrointesinal Lesion Software Detection System
Cleared on Jul 24, 2024 as substantially equivalent to DEN200055 (Cosmo Artificial Intelligence - Ai, Ltd., 2021) after a 201-day review. Its family tree reaches back 1 generation to 2021. 2 later devices descend from it.
- Decided
- Jul 24, 2024
- Review
- 201 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200055 (2021). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- This deviceK240044 CaddieOdin Medical Limited · 2024
- Descendant · cites it directly · 1 of its ownK252586 CaddieOdin Medical Limited · 2025
- Descendant · 2 generations on · 0 of its ownK260133 CaddieOdin Medical Limited · 2026
Most influential descendants
Showing 2 of 2 · See allView 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) | K240044 | Caddie | Odin Medical Limited | 2024 | — |
| +1 | K252586 | Caddie | Odin Medical Limited | 2025 | — |
| +2 | K260133 | Caddie | Odin Medical Limited | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 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 4…cation Name: Gastrointestinal Lesion Software Detection System Class: Class II Predicate Device: DEN200055 GI Genius - Cosmo Artificial Intelligence, AI LTD Device Description: CADDIE is cloud based artificial intelligence medical de… | 2021 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252586 | Caddie | 2025 | 1 |
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. 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 CADDIE computer-assisted detection device is intended to assist the gastroenterologist in detecting suspected colorectal polyps only. The gastroenterologist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment.
CADDIE is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. The CADDIE computer-assisted detection device is limited for use with standard white-light endoscopy imaging only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240044 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240044: Caddie.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240044
Report an extraction error
Are you the manufacturer?
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