Sleep Watch
FDA 510(k) clearance K251574 · decided 2025-07-31
Clearance details
- K-number
- K251574
- Device name
- Sleep Watch
- Applicant
- Ambulatory Monitoring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-22
- Decision date
- 2025-07-31
- Days to decision
- 70 days
- Clearance type
- Special
- Product code
- LEL
- Device class
- 2
- Regulation number
- 882.5050
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Ardsley, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EmbraceMini (K252981) | Empatica S.r.l. | 2025-12-22 |
| DCM (PW-DCM) (K243513) | Pneumowave, Ltd. | 2025-04-16 |
| VERABANDâ„¢ (K233987) | Arbor Medical Innovations, LLC | 2024-06-17 |
| Oxevision Sleep Device (K233618) | Oxehealth Limited | 2024-04-03 |
| ActiGraph LEAP activity monitor (ActiGraph LEAP) (K231532) | Actigraph, LLC | 2023-06-23 |
| ActiGraph CentrePoint Insight Watch (K181077) | Actigraph | 2018-05-24 |
| ActTrust (K151784) | Condor Instruments Ltda. - Epp | 2016-05-25 |
| MOTION WATCH AND PRO-DIARY (K132764) | Camntech, Ltd. | 2014-01-21 |
| SBV2, MULTICHARGER MODEL MC10V2 (K111514) | Sleep Performance D.B.A. Fatigue Science | 2011-12-16 |
| CADWELL LIMB MOVEMENT MODULE (K040986) | Cadwell Laboratories, Inc. | 2004-07-01 |
| EASYNET BODY POSITION MODULE (K040932) | Cadwell Laboratories, Inc. | 2004-07-01 |
| REMVIEW SLEEP RECORDER, MODEL 320 (K003499) | Respironics, Inc. | 2001-02-09 |
Recalls involving this device
No recalls on record reference this clearance.