510(k) · Cleared
ClearedSleep Watch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambulatory Monitoring, Inc. · LEL Device, Sleep Assessment
Cleared on Jul 31, 2025 as substantially equivalent to K854030 (Ambulatory Monitoring, Inc., 1986) after a 70-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jul 31, 2025
- Review
- 70 days
- Class
- Class II
- Product code
- LEL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854030 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- This deviceK251574 Sleep WatchAmbulatory Monitoring, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| 0 (this device) | K251574 | Sleep Watch | Ambulatory Monitoring, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LEL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LEL device
- #1 K252981 EmbraceMiniscore 23.3 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K854030 | Wrist ActigraphSummary page 5…Code Number Primary Wrist Actigraph Ambulatory Monitoring, Inc. LEL K854030 The predicate devices have not been subject to a design-related recall. 4. Device Description The Sleep Watch® is a wrist-worn… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K854030.
How does its category compare?
All LEL devicesLEL Device, Sleep Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LEL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LEL
96in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LEL
No recall names LEL since 2007.
Adverse event reports per year · LEL
1in 2021
MAUDE reports naming product code LEL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 3 | 96 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (175 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251574 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251574: Sleep Watch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251574
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026