# K233618: Oxevision Sleep Device

- Pathway: 510(k) (Traditional)
- Applicant: Oxehealth Limited
- Decided: Apr 3, 2024 after 142 days
- Product code: LEL (Device, Sleep Assessment)
- Device class: 2
- Regulation: 21 CFR 882.5050
- 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 K854030 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111514: SBV2, Multicharger Model MC10V2, Sleep Performance D.B.A. Fatigue Science (2011) Summary page 5.

## Indications for use
The Oxevision Sleep Device is an activity monitor designed and intended for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data. The device provides a timeline of periods when a bed space is occupied, and periods when a subject is asleep when the bed space is occupied. The Oxevision Sleep Device is software assessing video footage from a fixed-installation device for use within single occupancy bed spaces within hospitals, general care and secured environments. The Oxevision Sleep Device is indicated for use on subjects 18 years of age or older.

Source page: https://510kreport.com/device/K233618
Methodology: https://510kreport.com/methodology