Who is the manufacturer of Withings Sleep Rx?

Withings filed the 510(k) submission for Withings Sleep Rx (K231667).

What is the FDA product code for Withings Sleep Rx?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Withings Sleep Rx?

510(k) clearance (submission type: Traditional).

Does Withings Sleep Rx use AI or machine learning?

Yes. Withings Sleep Rx (K231667) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Withings Sleep Rx?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Withings Sleep Rx get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Withings Sleep Rx

K231667 · Withings · MNR · Sep 6, 2024 · Anesthesiology

Device Facts

Record ID	K231667
Device Name	Withings Sleep Rx
Applicant	Withings
Product Code	MNR · Anesthesiology
Decision Date	Sep 6, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	AI/ML

Intended Use

Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA). The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required. The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in lifethreatening situations.

Device Story

Contactless under-mattress device; uses pneumatic bladder pressure sensor and audio microphone to capture respiration, heart rate, and movement signals. Embedded microcontroller processes signals to calculate Withings index (breathing events per hour), heart rate, and movement. Data transmitted via Bluetooth/Wi-Fi to companion mobile app for clinician/patient review. Assists healthcare professionals in determining need for further sleep apnea evaluation. Not a substitute for full polysomnography; no real-time alarms.

Clinical Evidence

Clinical validation (NCT04234828) in 118 patients compared device to PSG. For AHI ≥ 15: sensitivity 0.88, specificity 0.886, AUC 0.926. For AHI ≥ 30: sensitivity 0.86, specificity 0.912, AUC 0.954. Heart rate estimation accuracy 0.9597 (lower bound 95% CI 0.9523). Internal movement detection study showed AUCs 0.89–0.94 for various movement classifications. All metrics met pre-defined acceptance criteria.

Technological Characteristics

Components: Mat (thermoplastic polyurethane bladder, polyester fabric), embedded software, companion app. Sensing: Pneumatic pressure sensor and audio microphone. Connectivity: Bluetooth Low Energy, Wi-Fi. Power: 5V. Dimensions: 637 x 195 x 24 mm. Software: Embedded microcontroller algorithms for signal processing, filtering, and parameter estimation.

Indications for Use

Indicated for adults ≤ 350 lbs with suspected sleep breathing disorders for home-screening and as an aid in diagnosing obstructive sleep apnea (OSA). Not for active patient monitoring or life-threatening situations.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

Drowzle (K173974)

Reference Devices

EarlySense Insight System (K152911)

Related Devices

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K250460 — WatchPAT400 (WP400) · Itamar Medical , Ltd. · Sep 5, 2025
K203343 — Wesper Lab · Wesper, Inc. · Dec 21, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 6, 2024 Withings Khushboo Surendran Regulatory Affairs Manager 2 Rue Maurice Hartmann Issy-Les-Moulineaux, Ile-De-France 92130 France # Re: K231667 Trade/Device Name: Withings Sleep Rx Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: August 5, 2024 Received: August 5, 2024 Dear Khushboo Surendran: 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. 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). {1}------------------------------------------------ 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 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-reportingcombination-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 Rue"). 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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). {2}------------------------------------------------ Sincerely, Digitally signed by Binoy J. Mathews -S Binoy J. Mathews -S Date: 2024.09.06 14:09:37 -04'00' For Rachana Visaria Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231667 Device Name Withings Sleep Rx #### Indications for Use (Describe) Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA). The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required. The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in lifethreatening situations. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;">☒ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | 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." {4}------------------------------------------------ # 510(k) Summary # 1. Submitter | Applicant: | Withings 2 Rue Maurice Hartmann Issy-Les-Moulineaux France 92130 | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Submission Correspondent: | Khushboo Surendran Regulatory Affairs Manager Phone: 857-233-2681 Email: khushboo.surendran@withings.com | | Back-Up Consulting Correspondent: | Michael Daniel Daniel & Daniel Consulting, LLC Email: madaniel@clinregconsult.com | Date Prepared: September 5th, 2024 # 2. Subject device Information | Device Name: | Withings Sleep Rx | |----------------------|-----------------------------| | Regulation name: | Breathing frequency monitor | | Regulation number: | 21 CFR 868.2375 | | | | | Regulatory Class: | Class II | | Product Code: | MNR | | 510(k) review panel: | Anesthesiology | # 3. Predicates Information | Predicate Manufacturer: | Resonea, Inc | |------------------------------------|---------------------------| | Predicate device name: | Drowzle | | Predicate 510(k) number: | K173974 | | Reference device Manufacturer: | EarlySense Ltd. | | Reference device name: | EarlySense Insight System | | Reference device 510(k) number: | K152911 | {5}------------------------------------------------ ### 4. Description of the device The Withings Sleep Rx is a device intended as an aid for diagnosis of obstructive sleep apnea (OSA). It is intended for home use. The device is placed under the mattress and is contactless with the user. It provides a Withings index based on breathing (sound, variations of pressure in the bladder) and heart rate measured in a contactless manner. The number of breathing events per hour is displayed to the user in the companion app. The results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. In addition, the device records heart rate and movement during sleep in an automatic contactless manner. The recordings are displayed in the companion app. Withings Sleep Rx is composed of the following components: (1) Mat (hardware); (2) Withings Sleep Rx embedded software included in the Mat and (3) Companion App included in a companion mobile application. ### 5. Indications for Use Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA). The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required. The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. # 6. Comparison table with subject device, predicate and reference device The following table presents a high-level comparison between the subject device (Withings Sleep Rx), the predicate device (Drowzle) and the reference device (EarlySense Bed Sensing Unit) for the indications for use, technological characteristics, and principle of operation. | Description | Subject device Withings Sleep Rx (K231667) | Predicate device Drowzle (K173974) | Reference device EarlySense Bed Sensing Unit (K152911) | Comparison (Similarities/ Differences) | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Withings Sleep Rx | Drowzle | EarlySense Insight System | N.A. | | Manufacturer | Withings | Resonea, Inc | EarlySense Ltd | N/A | | Regulation number | 868.2375 | 868.2375 | 868.2375 | Identical | | Description | Subject device Withings Sleep Rx (K231667) | Predicate device Drowzle (K173974) | Reference device EarlySense Bed Sensing Unit (K152911) | Comparison (Similarities/ Differences) | | Class | II | II | II | Identical | | Product code | MNR | MNR | BZQ | Identical to predicate | | 510(k) Review panel | Anesthesiology | Anesthesiology | Anesthesiology | Identical | | Prescription / OTC | Prescription | Prescription | Prescription | Identical | | Intended population | Adults | Adults | Adults, adolescents, and children | Identical to predicate. | | Intended environment for use | Home environment | Home environment | Home and Clinical environment | Identical to predicate. | | Intended Use | Home-use device for aiding to diagnosis patients with possible sleep disorders. | Home-use device for screening patients with possible sleep disorders. | Intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact- less manner. | Identical to predicate | | Indications for use | Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA). The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner. The device is designed for use in home- screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb | Drowzle is indicated to record a patient's respiratory pattern during sleep for the purpose of pre- screening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home- screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography | The EarlySense Bed Sensing Unit is an accessory that is compatible with bedside units of EarlySense Systems (Models 2.0 and InSight) intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner. Environment of use for the accessory is defined as per compatible cleared bedside units labeling: EarlySense 2.0 - at home, in hospital or clinic setting and InSight - in hospital or clinic setting. The device is indicated for use in children, adolescents and adults. | Identical to predicate. In addition, the indication for movement detection and heart rate estimation in a contact- less manner is identical to the reference device. | | Description | Subject device Withings Sleep Rx (K231667) | Predicate device Drowzle (K173974) | Reference device EarlySense Bed Sensing Unit (K152911) | Comparison (Similarities/ Differences) | | | movements, or EEG activity are required. The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life- threatening situations. | when additional parameters such as sleep stages, limb movements, or EEG activity are required. | The operation of the EarlySense system has been studied in children (weight ≥10 Kg) and adults (weight <111 Kg) during sleep and resting condition. | | | Device placement and patient contact | The Withings Sleep Rx is placed under the bed mattress - not touching the patient | Smartphone placed within 24 inches of pillow | The Bed Sensing Unit is placed under the bed mattress - not touching the patient | Identical. All the devices are contactless. | | Sensor Technology | A pneumatic bladder with a pressure sensor is used to detect motion signals (mechanical movements) in a contact-less manner. These signals are converted into an electrical signal, sampled, filtered and transferred to the embedded microcontroller where they are analyzed by the device's software (algorithms) to provide the Withings index, heart rate (HR), and movement. Bed exit signal is also detected and available. The signal of the pneumatic sensor is also decomposed into a breathing component by the algorithm (not shown to the patient). | N/A | Piezoelectric ceramic sensing element is used to detect motion signals (mechanical movements) in a contact-less manner. These signals are converted into an electric signal, sampled, filtered and transferred to the Bedside Unit where they are analyzed by the Bedside unit's software (algorithms) to provide the respiration rate (RR), heart rate (HR), and motion. Bed exit signal is also detected and available. | Similar to the reference device. Both devices detect motion signals (mechanical movements) in a contact less-manner. Both devices estimate the same parameters: heart rate (HR), movement and bed exit detection except for respiratory rate. | | | Device also includes an audio sensor | Microphone(s) native to smartphone placed | N/A | Similar to the predicate device. Both devices | | Description | Subject device Withings Sleep Rx (K231667) | Predicate device Drowzle (K173974) | Reference device EarlySense Bed Sensing Unit (K152911) | Comparison (Similarities/ Differences) | | | (microphone) that analyzes sound to identify breathing sound and estimates gaps in breathing sounds. | within 24 inches of pillow analyzes sound to identify breathing sound and estimates gaps in breathing sounds. | | are placed close to the user in a contactless manner to record breathing sounds. The subject device combines the breathing sounds with pressure changes measured by the pressure sensor to estimate respiratory events indicative of sleep apnea whereas the predicate device uses only the breathing sounds to estimate respiratory events indicative of sleep apnea. | | Material used | Inner bladder: thermoplastic polyurethane Outer Protective fabric: Polyester | N/A | ABS/Polycarbonate plate | Different. This difference does not affect safety due to the contactless nature of the device. | | Signals acquired | Sounds from respiration. Pressure changes due to body motion, chest movement (respiration), and vibrations created by the heart. | Sounds from respiration. | Piezoelectric signal generated by variations of pressure applied on the device due to body motion, chest movement (respiration), and vibrations created by the heart. | Similar to predicate and reference device | | Algorithm processing | Analyzes sound and pressure signals to identify respiratory events indicative of sleep apnea or other disorders. Analyzes the pressure signal to calculate heart rate and detect movements. | Analyzes the sound signal to identify respiratory events indicative of sleep apnea or other disorders | Analyzes the piezoelectric signal to calculate heart rate and respiration rate, and to detect movements. | The subject device analyzes the measured signals similarly to the predicate and reference device. | | Algorithm outputs displayed to the user | Withings index (estimated frequency of breathing events during sleep). | Resonea index (frequency of breathing events during sleep) | N/A | Similar to the predicate device | | Description | Subject device Withings Sleep Rx (K231667) | Predicate device Drowzle (K173974) | Reference device EarlySense Bed Sensing Unit (K152911) | Comparison (Similarities/ Differences) | | | - Heart Rate - Movement | N/A | - Heart Rate, - Motion - Respiration Rate - Bed occupancy data - Alerts | The subject and reference devices display heart rate and movement during the night. The subject device does not display respiration rate nor provides alerts. | | Definition of breathing events | Estimated amount of breathing sound gaps >10 seconds Average number of >10 second breathing sound gaps per hour | Estimated amount of breathing sound gaps >10 seconds Average number of >10 second breathing sound gaps per hour | N/A | Identical to the predicate device | | Heart rate range and accuracy | Range: 37 - 110 beats per minute Accuracy as compared to ECG heart rate: ±5 BPM | N/A | Range: 30 - 170 beats per minute Accuracy as compared to ECG heart rate: ±4% or ±5 BPM, whichever is greater | The range is different. The subject device labeling warns that the subject device is not intended f…

Withings Sleep Rx

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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Withings Sleep Rx

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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