510(k) · Cleared
ClearedSKOUT® system
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 Apr 7, 2023 as substantially equivalent to K213686 (Iterative Scopes, Inc., 2022) after a 29-day review. Its family tree reaches back 2 generations to 2021. 4 later devices descend from it.
- Decided
- Apr 7, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200055 (2021). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- 1 generation backK213686 SKOUT SoftwareIterative Scopes, Inc. · 2022
- This deviceK230658 SKOUT® systemIterative Scopes, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK240781 SKOUT® systemIterative Scopes, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK241508 SKOUT® systemIterative Scopes, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK251126 SKOUT systemIterative Health · 2025
- Descendant · 3 generations on · 0 of its ownK253664 SKOUT systemIterative Health · 2025
Most influential descendants
Showing 4 of 4 · See all- K240781SKOUT® systemIterative Scopes, Inc. · 2024 · cites it directly3descendants
- K241508SKOUT® systemIterative Scopes, Inc. · 2024 · 2 generations on2descendants
- K251126SKOUT systemIterative Health · 2025 · 2 generations on1descendant
- K253664SKOUT systemIterative Health · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| −1 | K213686 | SKOUT Software | Iterative Scopes, Inc. | 2022 | — |
| 0 (this device) | K230658 | SKOUT® system | Iterative Scopes, Inc. | 2023 | — |
| +1 | K240781 | SKOUT® system | Iterative Scopes, Inc. | 2024 | — |
| +2 | K241508 | SKOUT® system | Iterative Scopes, Inc. | 2024 | — |
| +2 | K251126 | SKOUT system | Iterative Health | 2025 | — |
| +3 | K253664 | SKOUT system | Iterative Health | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K213686 | SKOUT SoftwareSummary page 4…e Detection System Classification Panel: Gastroenterology and Urology Regulation Number: 876.1520 Product Code: QNP Predicate Device: SKOUT System, Iterative Scopes, K213686 Device Description The SKOUT⡶system is a software-based computer aided detection (CADe) system for the analysis of high- defin… | 2022 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240781 | SKOUT® system | 2024 | 3 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240781 (Iterative Scopes, Inc., 2024) has gone furthest, with 3 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. 2023, 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 as stated in the FDA summary.
https://510kreport.com/device/K230658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230658: SKOUT® system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230658
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