# K261367: Corsano CardioWatch 287-2 System

- Pathway: 510(k) (Traditional)
- Applicant: Corsano Health B.V.
- Decided: Jul 26, 2026 after 90 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 40 generations back to K941811 (1994). 357 ancestors in all.
No later device cites it as a predicate yet.
2 of 358 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232548: Corsano CardioWatch 287-2 System, Corsano Health B.V. (2024) Summary page 7.

## Indications for use
The CardioWatch 287-2 System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of non-acutely ill patients by trained healthcare professionals. The CardioWatch 287-2 System is intended to provide visual and audible physiologic multi-parameter alarms. The CardioWatch 287-2 System is intended for monitoring of skin temperature at wrist of the patient or axillary temperature with connected thermometer device. The CardioWatch 287-2 System is intended for continuous monitoring of the following physiological indices in adults (over 22years old): * Pulse rate » Oxygen saturation » Skin Temperature * Movement *» Sleep Assessment The CardioWatch 287-2 System is intended for intermittent monitoring with the CardioWatch Bracelet of the following physiological indices in adults (over 22years old): * Respiration rate. The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in adults, of: * Non-invasive blood pressure * Lung function & spirometry » Weight The CardioWatch 287-2 System is intended to monitor the activity associated with movement during sleep. The CardioWatch 287-2 System can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. The CardioWatch 287-2 System is not intended for use in high-acuity environments, such as ICU or operating rooms. The CardioWatch 287-2 System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The CardioWatch 287-2 system is not a substitute for an ECG monitor. The CardioWatch 287/-2 System is not intended tor SpO2 monitoring in conditions of high motion or low erfusion.

Source page: https://510kreport.com/device/K261367
Methodology: https://510kreport.com/methodology