Sleepiz One+ (2.5)

Q: When was Sleepiz One+ (2.5) cleared by the FDA?

Sleepiz One+ (2.5) (K251364) received a 510(k) decision of Substantially Equivalent on July 29, 2025, 89 days after the submission was received.

Q: What is the product code of K251364?

The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.

FDA 510(k) K251364 · Sleepiz AG

Substantially Equivalent

510(k) numberK251364

Submission

Device name: Sleepiz One+ (2.5)
Applicant: Sleepiz AG
Zurich, CH
Received: May 1, 2025
Decision date: July 29, 2025
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2300
Specialty: Cardiovascular

Other 510(k)s with product code DRT

510(k)	Device	Applicant	Decision
K261286	The Circadia C300 System (C300)DRT · Special	Circadia Health, Inc.	05/20/2026SE
K252676	The Circadia C300 System (C300)DRT · Traditional	Circadia Health, Inc.	02/03/2026SE
K253388	Sleepiz One+ (Model 2.5)DRT · Special	Sleepiz AG	01/28/2026SE
K234003	The Circadia C200 SystemDRT · Traditional	Circadia Technologies, Ltd.	05/30/2024SE
K232354	Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server…DRT · Traditional	Murata Vios, Inc.	03/22/2024SE
K231733	Neteera 130H-Plus Vital Sign Monitoring SensorDRT · Traditional	Neteera Technologies , Ltd.	02/09/2024SE
K223163	Sleepiz One+DRT · Traditional	Sleepiz AG	08/18/2023SE
K212143	Neteera 130H/131H Vital Sign Monitoring SensorDRT · Traditional	Neteera Technologies , Ltd.	09/28/2022SE
K202138	Cardiac Trigger MonitorDRT · Traditional	Ivy Biomedical Systems, Inc.	05/14/2021SE
K202464	Vital Sign Monitoring Sensor (Model :XK300)DRT · Traditional	Xandar Kardian, Inc.	04/26/2021SE

More from Xandar Kardian, Inc.

510(k)	Device	Decision
K253388	Sleepiz One+ (Model 2.5)DRT · Special	01/28/2026SE
K223163	Sleepiz One+DRT · Traditional	08/18/2023SE

Questions and answers

When was Sleepiz One+ (2.5) cleared by the FDA?

Sleepiz One+ (2.5) (K251364) received a 510(k) decision of Substantially Equivalent on July 29, 2025, 89 days after the submission was received.

What is the product code of K251364?

The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.