Cleared Traditional

K254230 - CapsoView (CVV)

Also marketed or referenced as:
CapsoCloud (CLD)

K254230 is an FDA 510(k) clearance for CapsoView (CVV), manufactured by CapsoVision, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code QZF cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K254230 · CapsoVision, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2026
Decision
270d
Days
Class 2
Risk

K254230 is an FDA 510(k) clearance for the CapsoView (CVV). Classified as Gastrointestinal Capsule Endoscopy Analysis Software Device (product code QZF), Class II - Special Controls.

Submitted by CapsoVision, Inc. (Saratoga, US). The FDA issued a Cleared decision on September 25, 2026 after a review of 270 days - an extended review cycle.

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. 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 CapsoVision, Inc. devices

FDA 510(k) Submission Details - K254230

510(k) Number K254230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date September 25, 2026
Days to Decision 270 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
139d slower than avg
Panel avg: 131d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QZF Device Classification - Class 2, Special Controls

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.