XK300 family. The XK300 is a Class II medical device, FDA-cleared (510(k) K202464) for measuring heart rate and breathing rate in adults, including in nursing homes and home healthcare, with clearances also in Canada, Australia, Singapore, Thailand and South Africa, manufactured under an ISO 13485 quality system audited through MDSAP. It is not an alarm system for acute or life-threatening events, and it does not diagnose any condition. Prescription use where applicable.
Figures and research. Early-notice figures on this site are retrospective findings from care settings and published work, part of ongoing discovery and research. They describe what the record showed, are not cleared indications, and are not claims. Heartbeat Clarity is investigational. XK does not predict or diagnose health events.
Kardian Somily is a separate general wellness product for individuals, sold at www.kardian.com. It is not a medical device and is not the cleared device.
Xandar Kardian, Kardian, XK300, Somily and Heartbeat Clarity are trademarks of Xandar Kardian Inc. Other names belong to their owners. This site is intended for healthcare professionals and organisations.