Sleep Watch
FDA 510(k) K251574 · Ambulatory Monitoring, Inc.
510(k) numberK251574
Submission
- Device name
- Sleep Watch
- Applicant
- Ambulatory Monitoring, Inc.
Ardsley, NY, US - Received
- May 22, 2025
- Decision date
- July 31, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LEL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252981 | EmbraceMiniLEL · Traditional | Empatica S.r.l. | 12/22/2025SE |
| K243513 | DCM (Pw-Dcm)LEL · Traditional | Pneumowave, Ltd. | 04/16/2025SE |
| K233987 | VerabandLEL · Traditional | Arbor Medical Innovations, LLC | 06/17/2024SE |
| K233618 | Oxevision Sleep DeviceLEL · Traditional | Oxehealth Limited | 04/03/2024SE |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP)LEL · Special | Actigraph, LLC | 06/23/2023SE |
| K181077 | ActiGraph CentrePoint Insight WatchLEL · Special | Actigraph | 05/24/2018SE |
| K151784 | ActTrustLEL · Traditional | Condor Instruments Ltda. - Epp | 05/25/2016SE |
| K132764 | Motion Watch and Pro-DiaryLEL · Traditional | Camntech, Ltd. | 01/21/2014SE |
| K111514 | SBV2, Multicharger Model MC10V2LEL · Traditional | Sleep Performance D.B.A. Fatigue Science | 12/16/2011SE |
| K040986 | Cadwell Limb Movement ModuleLEL · Traditional | Cadwell Laboratories, Inc. | 07/01/2004SE |
More from Cadwell Laboratories, Inc.
Questions and answers
When was Sleep Watch cleared by the FDA?
Sleep Watch (K251574) received a 510(k) decision of Substantially Equivalent on July 31, 2025, 70 days after the submission was received.
What is the product code of K251574?
The FDA product code is LEL – Device, Sleep Assessment, a Class II (moderate risk) device regulated under 21 CFR 882.5050.