Home / 510(k) Clearances / K253388

510(k) K253388

Sleepiz One+ (Model 2.5) by Sleepiz AG — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2026
Date Received
September 30, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Sleepiz AG

  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K223163 — Sleepiz One+ (August 18, 2023)

Other clearances for product code DRT

  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)
  • K202464 — Vital Sign Monitoring Sensor (Model :XK300) (April 26, 2021)
  • K181165 — Philips wearable biosensor-G5 Solution (March 7, 2019)