# K251574: Sleep Watch

- Pathway: 510(k) (Special)
- Applicant: Ambulatory Monitoring, Inc.
- Decided: Jul 31, 2025 after 70 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: 1 generation back to K854030 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854030: Wrist Actigraph, Ambulatory Monitoring, Inc. (1986) Summary page 5.

## Indications for use
A wrist-worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep and make estimates of sleep quantity/quality using accelerometry, based on actigraph algorithms designed specifically for the device's unique signal processing techniques. Can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. The results of the processed data are graphical and numerical presentations and reports of sleep latency, sleep duration, sleep quality and circadian rhythms for the use by or on the order of physicians, trained technicians, or other healthcare professionals. The Sleep Watch System is intended for use on a general-purpose computing platform, it does not issue any alarms. The Sleep Watch System is intended for use in the natural environment for passive, noninvasive, data collection of physiological parameters that will later be transmitted to a SaaS platform for remote review by a clinician. The Sleep Watch® device is intended for use in children and older.

Source page: https://510kreport.com/device/K251574
Methodology: https://510kreport.com/methodology