Cleared Traditional

K213686 - SKOUT Software (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213686 · Iterative Scopes, Inc. · Gastroenterology & Urology device
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Aug 2022
Decision
263d
Days
Class 2
Risk

K213686 is an FDA 510(k) clearance for the SKOUT Software. Classified as Gastrointesinal Lesion Software Detection System (product code QNP), Class II - Special Controls.

Submitted by Iterative Scopes, Inc. (Cambridge, US). The FDA issued a Cleared decision on August 12, 2022 after a review of 263 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1520 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Iterative Scopes, Inc. devices

Submission Details

510(k) Number K213686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2021
Decision Date August 12, 2022
Days to Decision 263 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 130d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNP Gastrointesinal Lesion Software Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1520
Definition A Gastrointestinal Lesion Software Detection System Is A Computer-assisted Detection Device Used In Conjunction With Endoscopy For The Detection Of Abnormal Lesions In The Gastrointestinal Tract. This Device With Advanced Software Algorithms Brings Attention To Images To Aid In The Detection Of Lesions. The Device May Contain Hardware To Support Interfacing With An Endoscope.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - QNP Gastrointesinal Lesion Software Detection System

All 18
Devices cleared under the same product code (QNP) and FDA review panel - the closest regulatory comparables to K213686.
MAGENTIQ-COLO (ME-APDS)
K260724 · Magentiq Eye, Ltd. · Apr 2026
SKOUT system
K253664 · Iterative Health · Dec 2025
MAGENTIQ-COLO (ME-APDS)
K252178 · Magentiq Eye, Ltd. · Oct 2025
CADDIE
K252586 · Odin Medical Limited · Sep 2025
SKOUT system
K251126 · Iterative Health · May 2025
MAGENTIQ-COLO (ME-APDS)
K244023 · Magentiq Eye, Ltd. · Jan 2025