Cleared Traditional

K261367 - Corsano CardioWatch 287-2 System

K261367 is the FDA 510(k) clearance for Corsano CardioWatch 287-2 System by Corsano Health B.V.. It is a Class 2 Neurology device (product code MSX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K261367 · Corsano Health B.V. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
90d
Days
Class 2
Risk

K261367 is an FDA 510(k) clearance for the Corsano CardioWatch 287-2 System. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Corsano Health B.V. (The Hague, NL). The FDA issued a Cleared decision on July 26, 2026 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.2300 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Corsano Health B.V. devices

Submission Details

510(k) Number K261367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2026
Decision Date July 26, 2026
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 Neurology devices follow this clearance model.

Regulatory Peers - MSX System, Network And Communication, Physiological Monitors

All 70
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K261367.
TigerConnect Alarm Management
K243270 · Tigerconnect · Sep 2025
BeneVision Central Monitoring System
K242728 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2025
Central Station
K242750 · Nihon Kohden Digital Health Solutions, LLC · Jun 2025
ANNE View, Central Hub
K242842 · Sibel Health, Inc. · Jan 2025
Hinscope
K241397 · Hinlab Sas · Nov 2024
Infinity Gateway Suite
K233834 · Draeger Medical Systems, Inc. · Jul 2024