# K251364: Sleepiz One+ (2.5)

- Pathway: 510(k) (Special)
- Applicant: Sleepiz AG
- Decided: Jul 29, 2025 after 89 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: 6 generations back to K830295 (1983). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223163: Sleepiz One+, Sleepiz AG (2023) Summary page 5.

## Most influential descendants
- 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) and to detect patient presence and body movements. 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+ cloud software is intended for use by healthcare professionals. 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/K251364
Methodology: https://510kreport.com/methodology