Cleared Traditional

K232548 - Corsano CardioWatch 287-2 System

K232548 is an FDA 510(k) clearance for Corsano CardioWatch 287-2 System, manufactured by Corsano Health B.V.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K232548 · Corsano Health B.V. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
212d
Days
Class 2
Risk

K232548 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. (S'-Gravenhage, NL). The FDA issued a Cleared decision on March 22, 2024 after a review of 212 days - an extended review cycle.

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

View all Corsano Health B.V. devices

FDA 510(k) Submission Details - K232548

510(k) Number K232548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2023
Decision Date March 22, 2024
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
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 Cardiovascular devices follow this clearance model.

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

All 73
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K232548.
Hinscope
K241397 · Hinlab Sas · Nov 2024
Infinity Gateway Suite
K233834 · Draeger Medical Systems, Inc. · Jul 2024
Biofourmis Everion+ (G2)
K233418 · Biofourmis Singapore Pte., Ltd. · May 2024
Current Health System
K231506 · Current Health , Ltd. · Aug 2023
CNS-2101 Central Monitor
K223567 · Nihon Kohden Corporation · Jul 2023
Everion+ System
K213863 · Biofourmis Singapore Pte., Ltd. · Feb 2023