FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Sleepiz One+ (Model 2.5)
K Number: K253388
·
Decision Jan 28, 2026
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
3
Review Days
120
Basic Information
- Device Name
- Sleepiz One+ (Model 2.5)
- K Number
- K253388
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sleepiz AG
- Date Received
- September 30, 2025
- Decision Date
- January 28, 2026
- Product Code
- DRT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRT), ordered by most recent decision date.
The Circadia C300 System (C300)
FDA 510(k)
FDA Class 2
·Cardiovascular
The Circadia C300 System (C300)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sleepiz One+ (2.5)
FDA 510(k)
FDA Class 2
·Cardiovascular
The Circadia C200 System
FDA 510(k)
FDA Class 2
·Cardiovascular
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
FDA 510(k)
FDA Class 2
·Cardiovascular
Neteera 130H-Plus Vital Sign Monitoring Sensor
FDA 510(k)
FDA Class 2
·Cardiovascular