510(k) · Cleared
ClearedSKOUT Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iterative Scopes, Inc. · QNP Gastrointesinal Lesion Software Detection System
Cleared on Aug 12, 2022 as substantially equivalent to DEN200055 (Cosmo Artificial Intelligence - Ai, Ltd., 2021) after a 263-day review. Its family tree reaches back 1 generation to 2021. 5 later devices descend from it.
- Decided
- Aug 12, 2022
- Review
- 263 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200055 (2021). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- This deviceK213686 SKOUT SoftwareIterative Scopes, Inc. · 2022
- Descendant · cites it directly · 4 of its ownK230658 SKOUT® systemIterative Scopes, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK240781 SKOUT® systemIterative Scopes, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK241508 SKOUT® systemIterative Scopes, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK251126 SKOUT systemIterative Health · 2025
- Descendant · 4 generations on · 0 of its ownK253664 SKOUT systemIterative Health · 2025
Most influential descendants
Showing 5 of 5 · See all- K230658SKOUT® systemIterative Scopes, Inc. · 2023 · cites it directly4descendants
- K240781SKOUT® systemIterative Scopes, Inc. · 2024 · 2 generations on3descendants
- K241508SKOUT® systemIterative Scopes, Inc. · 2024 · 3 generations on2descendants
- K251126SKOUT systemIterative Health · 2025 · 3 generations on1descendant
- K253664SKOUT systemIterative Health · 2025 · 4 generations on0descendants
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) | K213686 | SKOUT Software | Iterative Scopes, Inc. | 2022 | — |
| +1 | K230658 | SKOUT® system | Iterative Scopes, Inc. | 2023 | — |
| +2 | K240781 | SKOUT® system | Iterative Scopes, Inc. | 2024 | — |
| +3 | K241508 | SKOUT® system | Iterative Scopes, Inc. | 2024 | — |
| +3 | K251126 | SKOUT system | Iterative Health | 2025 | — |
| +4 | K253664 | SKOUT system | Iterative Health | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | DEN200055 | GI GeniusSummary page 4…Classification Panel: Gastroenterology and Urology Regulation Number: 876.1520 Product Code: QNP Predicate Device: GI Genius, Cosmo Artificial Intelligence - AI, LTD, DEN200055 Device Description The SKOUTTM system is a software-based computer aided detection (CADe) system for the analysis of high-defin… | 2021 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230658 | SKOUT® system | 2023 | 4 |
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. 2022, 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 SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. The SKOUT system is only…
Read the full statement (140 words)
The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
The SKOUT system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT 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. SKOUT is indicated for white light colonoscopy only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213686: SKOUT Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213686
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