510(k) · Cleared
ClearedSKOUT system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iterative Health · QNP Gastrointesinal Lesion Software Detection System
Cleared on May 9, 2025 as substantially equivalent to K240781 (Iterative Scopes, Inc., 2024) and 1 other predicate after a 28-day review. Its family tree reaches back 5 generations to 2021. 1 later device descends from it.
- Decided
- May 9, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to DEN200055 (2021). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- 4 generations backK213686 SKOUT SoftwareIterative Scopes, Inc. · 2022
- 3 generations backK230658 SKOUT® systemIterative Scopes, Inc. · 2023
- 2 generations backK240781 SKOUT® systemIterative Scopes, Inc. · 2024
- 1 generation backK241508 SKOUT® systemIterative Scopes, Inc. · 2024
- This deviceK251126 SKOUT systemIterative Health · 2025
- Descendant · cites it directly · 0 of its ownK253664 SKOUT systemIterative Health · 2025
Most influential descendants
Showing 1 of 1 · See all- K253664SKOUT systemIterative Health · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| −4 | K213686 | SKOUT Software | Iterative Scopes, Inc. | 2022 | — |
| −3 | K230658 | SKOUT® system | Iterative Scopes, Inc. | 2023 | — |
| −2 | K240781 | SKOUT® system | Iterative Scopes, Inc. | 2024 | — |
| −1 | K241508 | SKOUT® system | Iterative Scopes, Inc. | 2024 | — |
| 0 (this device) | K251126 | SKOUT system | Iterative Health | 2025 | — |
| +1 | K253664 | SKOUT system | Iterative Health | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K240781 | SKOUT® systemSummary page 5…tion Name: Gastrointestinal lesion software detection system (21 CFR 876.1520, Product Code QNP) Predicate Device: SKOUT® system, Iterative Scopes, K240781 Device Description The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of high-defini… | 2024 |
| * | K241508 | SKOUT® systemSummary page 6…olonoscopy only. Summary of Technological Characteristics The subject device is a modified version of the predicate device, which was cleared on July 3, 2024 (K241508). The key characteristics of the subject SKOUT® system and the predicate SKOUT® system are compared in the following table.… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253664 | SKOUT system | 2025 | 0 |
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 4 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K253664 (Iterative Health, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K240781.
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. 2025, 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/K251126 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251126: SKOUT system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251126
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