Cleared Traditional

K261367 - Corsano CardioWatch 287-2 System

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

K261367 · Corsano Health B.V. · Neurology device
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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

FDA 510(k) Submission Details - K261367

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
Combination Product No
PCCP Authorized No
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.

MSX Device Classification - Class 2, Special Controls

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 103
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