Cleared Traditional

K250655 - Deep Capsule® (Deep Capsule US) (FDA 510(k) Clearance)

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

K250655 · Digestaid - Artificial Intelligence Development SA · Gastroenterology & Urology device
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Mar 2026
Decision
372d
Days
Class 2
Risk

K250655 is an FDA 510(k) clearance for the Deep Capsule® (Deep Capsule US). Classified as Gastrointestinal Capsule Endoscopy Analysis Software Device (product code QZF), Class II - Special Controls.

Submitted by Digestaid - Artificial Intelligence Development SA (Gondomar, PT). The FDA issued a Cleared decision on March 12, 2026 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1540 - 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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K250655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2025
Decision Date March 12, 2026
Days to Decision 372 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
242d slower than avg
Panel avg: 130d · This submission: 372d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QZF Gastrointestinal Capsule Endoscopy Analysis Software Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1540
Definition A Gastrointestinal Capsule Endoscopy Analysis Software Device Is Used To Analyze Pre-recorded Capsule Endoscopy Videos Of The Gastrointestinal Tract That Are Suspected Of Containing Lesions. This Device Uses Software Algorithms To Identify Images And Areas Of Interest As Outputs To Aid The Clinician In Analyzing Suspected Lesions, For Clinician Review Of Device Outputs. The Device May Contain Hardware To Support Interfacing With A Capsule Imaging System.
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.