# K223163: Sleepiz One+

- Pathway: 510(k) (Traditional)
- Applicant: Sleepiz AG
- Decided: Aug 18, 2023 after 315 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- 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: 5 generations back to K830295 (1983). 19 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202464: Vital Sign Monitoring Sensor (Model :XK300), Xandar Kardian, Inc. (2021) Summary page 5.

## Most influential descendants
- K251364: Sleepiz One+ (2.5) (2025), 1 descendant of its own
- K254058: DistaSense (TM) (v1) (2026), 0 descendants of its own
- K253388: Sleepiz One+ (Model 2.5) (2026), 0 descendants of its own

## Indications for use
Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition). The Sleepiz One+ hardware unit is intended to be used by a healthcare professional when the recordings are performed in a clinical setting, or by patients or their caregivers when the recordings are performed in a home environment. The Sleepiz One+ web application is intended for use by healthcare professionals. Sleepiz One+ device can also detect the presence of patients and their body movements at rest or during sleep. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not indicated for use on pregnant women or patients with active implantable devices.

Source page: https://510kreport.com/device/K223163
Methodology: https://510kreport.com/methodology