Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition) and to detect patient presence and body movements.

The Sleepiz One+ hardware unit is intended to be used by a healthcare professional when the recordings are performed in a clinical setting, or by patients or their caregivers when the recordings are performed in a home environment. The Sleepiz One+ cloud software is intended for use by healthcare professionals. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not indicated for use on pregnant women.

Device Description

Sleepiz One+ is a contactless medical device that uses radar technology to measure respiration rate and heart rate from a resting or sleeping patient.

The Sleepiz One+ consists of a hardware unit and cloud-based software. The hardware unit can be positioned on a bedside table, mounted on a stand, or attached to the wall behind the patient's bed. It is designed to monitor physiological signals by detecting small body movements, such as those caused by breathing and heartbeat, using Doppler radar. The recorded signals are then transmitted via Wi-Fi to cloud-based software, where they are analyzed to obtain respiration rate, heart rate, and body movement. These outputs can be exposed via the Application Programming Interfaces (APIs) to allow healthcare professionals the review and annotation of the data and compilation of results into reports.

Outputs:

Breathing pattern
Instantaneous breathing rate [breaths per minute]
Breathing rate statistics (10th, 50th, and 90th quantiles) [breaths per minute]
Body movement
Time in bed [hours]
Presence detection
Heart rate [beats per minute]
Heart rate statistics (10th, 50th, and 90th quantiles) [beats per minute]

The overall system can be grouped into 4 major components, which are classified on the basis of the logical component interfaces where data exchange is occurring:

Sleepiz Hardware - This is a hardware component serving as primary data acquisition device.
Embedded Software - This encompasses the firmware running of the Sleepiz Hardware. This, together with Sleepiz hardware, is responsible for data acquisition. The embedded software forms the crux of the Sleepiz hardware such that it defines and controls the data acquisition process. The security aspects related to the operation of the device are incorporated in the design and implementation of embedded software.
Sleep Analytics Software - The sleep analytics software is responsible for processing data from the Sleepiz Hardware and returning its analytics (e.g., breathing rate, heart rate), as well as its statistics (e.g., mean breathing rate, total recording time, etc.). This refers to the ML model deployed within the cloud software. By itself, the Sleep Analytics Software does not have an external interface. It is wholly encapsulated by the cloud software component Data Processing Layer.
Cloud Software - The cloud software can be divided into the backend service and the analytics service. The backend service includes modules for data ingestion, a public API, a private API, and a module for sending analysis process requests. The analytics service is responsible for receiving analysis requests and interacting with the sleep analytics software.

AI/ML Overview

The provided FDA 510(k) clearance letter for the Sleepiz One+ (Model 2.5) indicates that no new non-clinical or clinical testing was required for this specific submission (K253388). The device is stated to be identical in design, materials, intended use, and technological characteristics to its predicate device (Sleepiz One+, K251364). Therefore, the information regarding acceptance criteria and a study to prove the device meets these criteria would pertain to the predicate device's clearance.

Based on the provided text, we can infer the following about acceptance criteria and the study that would have supported the predicate device (Sleepiz One+, K251364):

Since the current clearance states "The previous testing and clinical evidence supporting the predicate remain applicable," the information requested relates to what would have been submitted for the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list the acceptance criteria or reported device performance for the predicate device. However, based on the stated intended use and functionality, the performance would likely be evaluated based on the accuracy of:

Parameter	Acceptance Criteria (Inferred)	Reported Device Performance (Not provided in this document)
Heart Rate Accuracy	Within a specified range of a reference standard (e.g., medical-grade ECG)	(Details not provided in this document)
Respiration Rate Accuracy	Within a specified range of a reference standard (e.g., medical-grade capnography or pneumotachograph)	(Details not provided in this document)
Patient Presence Detection Accuracy	High sensitivity and specificity for detecting patient presence	(Details not provided in this document)
Body Movement Detection Accuracy	Ability to reliably detect and differentiate major body movements from physiological signals	(Details not provided in this document)

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the current 510(k) document. For the predicate device, a clinical study would have been conducted to validate the accuracy of heart rate and respiration rate measurements against a gold standard. The sample size would depend on statistical power requirements to demonstrate equivalence or non-inferiority to the reference device. The data provenance (e.g., country of origin, retrospective/prospective) would also be detailed in the predicate's submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the current 510(k) document. For the predicate device, if ground truth involved human interpretation (e.g., for certain types of sleep events, though unlikely for automated HR/RR), the number and qualifications of experts would be specified (e.g., board-certified pulmonologists or sleep specialists with X years of experience). For HR/RR, the "ground truth" would more likely come from concurrent measurements from established medical devices.

4. Adjudication Method for the Test Set

This information is not provided in the current 510(k) document. For the predicate device, if multiple experts were involved in establishing ground truth (which is less likely for direct physiological measurements like HR/RR), the adjudication method (e.g., 2+1, 3+1 consensus, majority vote) would be detailed. For physiological measurements, adjudication typically involves comparing automated readings against a validated reference device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided in the current 510(k) document. An MRMC study is typically performed for AI devices that assist human readers in interpreting complex images or signals. Since the Sleepiz One+ is a direct measurement device (heart rate, respiration rate, presence, movement), an MRMC study comparing human readers with and without AI assistance is unlikely to be relevant for its primary functions. The device directly outputs physiological parameters, not interpretations for human review.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Based on the device description, where "recorded signals are then transmitted via Wi-Fi to cloud-based software, where they are analyzed to obtain respiration rate, heart rate, and body movement," a standalone performance study would have been conducted for the predicate device. The study would evaluate the algorithm's accuracy in autonomously determining heart rate, respiration rate, presence, and movement against a ground truth.

7. Type of Ground Truth Used

For the predicate device, the ground truth for heart rate and respiration rate measurements would most likely be established using validated medical-grade reference devices (e.g., electrocardiogram (ECG) for heart rate, capnography or pneumotachograph for respiration rate) concurrently with the Sleepiz One+ device. For presence and body movement, the ground truth could be established by observation, video recording, or other motion sensors.

8. Sample Size for the Training Set

This information is not provided in the current 510(k) document. For the predicate device, data from human subjects would have been collected to train the machine learning models (specifically the "Sleep Analytics Software / ML model deployed within the cloud software"). The size and diversity of this training set are critical for the model's generalizability and accuracy.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the current 510(k) document. Similar to the test set, the ground truth for the training set for the predicate device would have been established by concurrent recording with validated medical-grade reference devices for heart rate and respiration rate. This would involve recording signals from patients simultaneously with both the Sleepiz device and the reference device, allowing for the precise labeling of heartbeats, breaths, and movements in the training data.

Summary

FDA 510(k) Clearance Letter - Sleepiz One+ (Model 2.5)

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January 28, 2026

Sleepiz AG
Marta Stepien
Vice-President of Clinical, Regulatory and Quality Affairs
Hornbachstrasse 23
Zurich, 8008
Switzerland

Re: K253388
Trade/Device Name: Sleepiz One+ (Model 2.5)
Regulation Number: 21 CFR 870.2300
Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm)
Regulatory Class: Class II
Product Code: DRT, BZQ
Dated: December 23, 2025
Received: December 29, 2025

Dear Marta Stepien:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K253388 - Marta Stepien Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K253388 - Marta Stepien Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

JENNIFER W. SHIH -S

Jennifer Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K253388

Device Name
Sleepiz One+ (2.5)

Indications for Use (Describe)
Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition) and to detect patient presence and body movements.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K253388

Device Name
Sleepiz One+ (2.5)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

510(k) Summary

510(k) #: K253388
Prepared on: 2025-12-23

Contact Details - 21 CFR 807.92(a)(1)

Applicant Name	Sleepiz AG
Applicant Address	Hornbachstrasse 23 Zurich Zurich 8008 Switzerland
Applicant Contact Telephone	+41 76 783 73 5
Applicant Contact	Marta Stepien
Applicant Contact Email	marta.stepien@sleepiz.com

Device Name - 21 CFR 807.92(a)(2)

Device Trade Name	Sleepiz One+ (2.5)
Common Name	Cardiac Monitor (including cardiotachometer and rate alarm)
Classification Name	Cardiac Monitor (including cardiotachometer and rate alarm)
Regulation Number	870.2300
Product Code(s)	DRT, BZQ

Legally Marketed Predicate Devices - 21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K251364	Sleepiz One+	DRT

Device Description Summary - 21 CFR 807.92(a)(4)

Sleepiz One+ is a contactless medical device that uses radar technology to measure respiration rate and heart rate from a resting or sleeping patient.

Outputs:

Breathing pattern
Instantaneous breathing rate [breaths per minute]
Breathing rate statistics (10th, 50th, and 90th quantiles) [breaths per minute]
Body movement
Time in bed [hours]
Presence detection
Heart rate [beats per minute]
Heart rate statistics (10th, 50th, and 90th quantiles) [beats per minute]

The overall system can be grouped into 4 major components, which are classified on the basis of the logical component interfaces where data exchange is occurring:

Sleepiz Hardware - This is a hardware component serving as primary data acquisition device.
Embedded Software - This encompasses the firmware running of the Sleepiz Hardware. This, together with Sleepiz hardware, is responsible for data acquisition. The embedded software forms the crux of the Sleepiz hardware such that it defines and controls the

Page 6

data acquisition process. The security aspects related to the operation of the device are incorporated in the design and implementation of embedded software.

Sleep Analytics Software - The sleep analytics software is responsible for processing data from the Sleepiz Hardware and returning its analytics (e.g., breathing rate, heart rate), as well as its statistics (e.g., mean breathing rate, total recording time, etc.). This refers to the ML model deployed within the cloud software. By itself, the Sleep Analytics Software does not have an external interface. It is wholly encapsulated by the cloud software component Data Processing Layer.
Cloud Software - The cloud software can be divided into the backend service and the analytics service. The backend service includes modules for data ingestion, a public API, a private API, and a module for sending analysis process requests. The analytics service is responsible for receiving analysis requests and interacting with the sleep analytics software.

Intended Use/Indications for Use - 21 CFR 807.92(a)(5)

Indications for Use Comparison - 21 CFR 807.92(a)(5)

The subject device is identical to the predicate device with respect to intended use, use environment, and monitored parameters. The only labeling modification pertains to the removal of the contraindication related to use in individuals with active implantable medical devices (e.g., pacemakers). This modification does not change the fundamental technology or performance characteristics of the device. The removal is justified based on EMC testing, attenuation analysis, scientific literature, and a comparative review of similar 510(k) cleared marketed devices.

Accordingly, the subject device remains substantially equivalent to the predicate device, and the labeling change does not raise new questions of safety or effectiveness.

Technological Comparison - 21 CFR 807.92(a)(6)

The subject device is identical to the predicate device and utilizes same radar technology to acquire patient physiological signals. The acquired data are transmitted via the Internet to the backend server in both devices. Both the subject and predicate devices use the same Application Programming Interface (API) links, enabling physicians to access patient data through third-party systems. Additionally, both devices operate using the same plug-in power source.

The subject device has identical technological characteristics compared to the predicate device and is therefore substantially equivalent in terms of design, materials, principle of operation, and energy source.

Non-Clinical and/or Clinical Tests Summary & Conclusions - 21 CFR 807.92(b)

No new non-clinical or clinical testing was required for the subject device, as it is identical in design, materials, intended use, and technological characteristics to the predicate device. The previous testing and clinical evidence supporting the predicate remain applicable.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).