FDA 510(k) · Ambulatory Monitoring
K251574: Sleep Watch (Ambulatory Monitoring, Inc.)
Ambulatory Monitoring, Inc. received FDA 510(k) K251574 for Sleep Watch, with a decision date of Jul 31, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K251574 |
|---|---|
| Pathway | 510(k) |
| Applicant | Ambulatory Monitoring, Inc. |
| Device name | Sleep Watch |
| Product code | LEL: Device, Sleep Assessment |
| Regulation (21 CFR) | 882.5050 |
| Device class | Class 2 |
| Date received | May 22, 2025 |
| Decision date | Jul 31, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code LEL is "Device, Sleep Assessment", class 2, 21 CFR 882.5050.
Our labels for filtering: claim Sleep, sensor Wrist PPG. These are heuristics, not FDA fields.