Who is the manufacturer of DeepRESP?

Nox Medical Ehf filed the 510(k) submission for DeepRESP (K241960).

What is the FDA product code for DeepRESP?

OLZ. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for DeepRESP?

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

Does DeepRESP use AI or machine learning?

Yes. DeepRESP (K241960) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for DeepRESP?

Nox Sleep System (K192469); Sleepware G3 (K202142).

Who can help prepare an FDA 510(k) submission like DeepRESP?

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 DeepRESP 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.

DeepRESP

K241960 · Nox Medical Ehf · OLZ · Mar 14, 2025 · Neurology

Device Facts

Record ID	K241960
Device Name	DeepRESP
Applicant	Nox Medical Ehf
Product Code	OLZ · Neurology
Decision Date	Mar 14, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, patient home, or an ambulatory setting. It is indicated for use with adults (22 years and above) in a clinical environment by or on the order of a medical professional. DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotation of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional.

Device Story

DeepRESP is a cloud-based SaMD for analyzing sleep study recordings. Inputs include EEG, chin EMG, EOG, abdominal/thoracic RIP, SpO2, nasal pressure, and body position. The device uses AI and rule-based models to perform automated sleep staging, arousal scoring, and respiratory event scoring (e.g., AHI). It operates on a serverless cloud stack, interfacing via a web API with third-party client applications. Medical professionals use the output to assist in diagnosing sleep disorders; all automated results require manual verification. The device benefits patients by providing standardized, automated analysis of sleep data, facilitating efficient clinical review and diagnosis.

Clinical Evidence

Retrospective study using 2,224 Type I and 3,488 Type III sleep recordings from US clinics. Validated against manual scoring and compared to Nox Sleep System (respiratory/sleep staging) and Sleepware G3 (arousal scoring). For Type I: AHI ≥5 PPA 87.5%, OPA 87.9%; AHI ≥15 PPA 74.1%, OPA 81.5%. For Type III: AHI ≥5 PPA 93.1%, OPA 92.5%; AHI ≥15 PPA 82.1%, OPA 84.7%. Results demonstrate non-inferiority/superiority to predicates across primary endpoints.

Technological Characteristics

Cloud-based SaMD hosted on a serverless stack. Utilizes AI and rule-based models for signal analysis. Inputs: EEG, EMG, EOG, RIP, SpO2, nasal pressure, body position. Standards: IEC 62304:2006/A1:2015, ISO 14971:2019, ANSI/AAMI SW96:2023. Connectivity: Web API for third-party client integration. Data storage: Object storage service.

Indications for Use

Indicated for adults (22+ years) undergoing sleep disorder evaluation or treatment follow-up in clinical, home, or ambulatory settings. Used as an aid for sleep study signal marking, event identification, trace annotation, automated measurement calculation, and sleep staging (with or without EEG).

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

Nox Sleep System (K192469)
Sleepware G3 (K202142)

Related Devices

K252330 — DeepRESP · Nox Medical Ehf · Nov 17, 2025
K221179 — SomnoMetry · Neumetry Medical, Inc. · Sep 21, 2022
K253668 — Onera SleepMap (SLEEPMAP) · Onera B.V. · Mar 8, 2026
K260585 — Noxturnal Web · Nox Medical Ehf · Mar 20, 2026
K241288 — Noxturnal Web · Nox Medical Ehf · Dec 23, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ March 14, 2025 Image /page/0/Picture/1 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Nox Medical ehf % Hrishikesh Gadagkar Senior Principal Ram+ 2790 Mosside Blvd #800 Monroeville, Pennsylvania 15146 Re: K241960 Trade/Device Name: DeepRESP Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: July 3, 2024 Received: July 3, 2024 Dear Hrishikesh Gadagkar: 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 (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" {1}------------------------------------------------ (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 OS 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-devices/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 mediation-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, # Patrick Antkowiak -S for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K241960 Device Name DeepRESP #### Indications for Use (Describe) DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, patient home, or an ambulatory setting. It is indicated for use with adults (22 years and above) in a clinical environment by or on the order of a medical professional. DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotation of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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." {4}------------------------------------------------ 510(k) Summary DeepRESP – 510(k) Traditional ## DATE PREPARED March 13, 2025 ## MANUFACTURER AND 510(k) OWNER Nox Medical ehf Katrinartuni 2, IS - 105 Reykjavik, Iceland Telephone: +354 570 7170 Official Contact: Kolbrun E Ottosdottir, Chief Compliance Officer ## REPRESENTATIVE/CONSULTANT Hrishikesh Gadagkar, Sr. Principal RQM+ 2790 Mosside Blvd #800, Monroeville, PA Telephone: +1 (410) 245-0501 Email: hgadagkar@rqmplus.com ## DEVICE INFORMATION | Proprietary Name/Trade Name: | DeepRESP | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Electroencephalograph, Automatic Event Detection Software for Polysomnograph with Electroencephalograph | | Regulation Number: | 882.1400 | | Class: | II | | Product Code: | OLZ | | Premarket Review: | Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A), Office of Neurological and Physical Medicine Devices (OHT5) | | Review Panel: | Neurology | ## PREDICATE DEVICE IDENTIFICATION The DeepRESP is substantially equivalent to the following predicate: | 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate | Additional Predicate | |------------------|--------------------------------------|----------------------|-------------------------| | K192469 | Nox Sleep System / Nox Medical | x | | | K202142 | Sleepware G3 / Respironics Inc | | x | ## DEVICE DESCRIPTION DeepRESP is a cloud-based software as a medical device (SaMD), designed to perform analysis of sleep study recordings, with and without EEG signals, providing data for the assessment and diagnosis of sleep-related disorders. Its algorithmic framework provides the derivation of sleep staging including arousals, scoring of respiratory events and key parameters such as the Apnea-Hypopnea Index (AHI). {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the text "nox medical" in a sans-serif font. The text is dark blue and appears to be a logo or brand name. The words are lowercase and evenly spaced. 510(k) Summarv DeepRESP – 510(k) Traditional DeepRESP is hosted on a serverless stack. It consists of: - A web Application Programming Interface (API) intended to interface with a third-party ● client application, allowing medical professionals to access DeepRESP's analytical capabilities. - Predefined sequences called Protocols that run data analyses, including artificial . intelligence and rule-based models for the scoring of sleep studies, and a parameter calculation service. - A Result storage using an object storage service to temporarily store outputs from the . DeepRESP Protocols. Image /page/5/Figure/6 description: The image is a dataflow diagram titled "Figure 1 - DeepRESP dataflow". The diagram shows the flow of data between different components, including the EMR Repository, Client application, DeepRESP API, DeepRESP Protocols, and DeepRESP Result storage. The EMR Repository and Client application are connected by a two-way arrow, indicating that data can flow in both directions. The Client application is connected to the DeepRESP API, which is connected to the DeepRESP Protocols, which is connected to the DeepRESP Result storage. INDICATIONS FOR USE DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, patient home, or an ambulatory setting. It is indicated for use with adults (22 years and above) in a clinical environment by or on the order of a medical professional. DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotation of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Nox Medical believes that the DeepRESP is substantially equivalent to the primary predicate device based on the information summarized here: {6}------------------------------------------------ 510(k) Summary DeepRESP – 510(k) Traditional | Trade/Device Name | Subject Device: | Primary Predicate Device: | Additional Predicate Device: | |---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | DeepRESP | Nox Sleep System | Sleepware G3 | | Manufacturer | Nox Medical | Nox Medical | Respironics, Inc. | | 510(k) Number | K241960 | K192469 | K202142 | | Regulation Number | 21 CFR 882.1400 | 21 CFR 882.1400 | 21 CFR 882.1400 | | Regulation Name | Electroencephalograph | Electroencephalograph | Electroencephalograph | | Regulatory Class | Class II | Class II | Class II | | Product Code(s) | OLZ | Primary: OLZ Subsequent: KZM | OLZ | | Intended Use | DeepRESP is a cloud-based artificial intelligence- enabled software application used for analysis (automatic scoring), retrieval, and summarization of data recorded with sleep monitoring devices. The device uses an algorithm to categorize sleep- related events that help aid in the diagnosis of sleep-related disorders. The results of the analyzed data are then transferred to another software for manual scoring, display and reporting | The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake.The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre-defined reports based on subject´s data. The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home. | Sleepware G3 is a software application used for analysis (automatic and manual scoring), display, retrieval, summarization, report generation, and networking of data received from monitoring devices used to categorize sleep related events that help aid in the diagnosis of sleep-related disorders. The optional Somnolyzer software application is intended to mark sleep study signals in order to aid in the identification of events and annotation of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); and infer sleep staging in the absence of EEG. All output subject to verification by a qualified user. | | Indications for Use | DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be | The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, | Sleepware G3 is a software application used for analysis (automatic and manual scoring), display, retrieval, summarization, report generation, and networking of data received from monitoring devices | | | analyzed by DeepRESP can be performed in a hospital, patient home, or an ambulatory setting. It is indicated for use with adults (22 years and above) in a clinical environment by or on the order of a medical professional. DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotation of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional. | display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre-defined reports based on subject 's data. The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home. | used to categorize sleep related events that help aid in the diagnosis of sleep-related disorders. It is indicated for use with adults (18 and older) and infant patients (one year old or less) in a clinical environment by or on the order of a physician. The optional Somnolyzer scoring algorithms are for use with adults (18 and older) to generate an output that is ready for review and interpretation by a physician. Cardio-Respiratory Sleep Staging (CReSS) is an additional functionality of Somnolyzer which uses standard Home Sleep Apnea Test HSAT signals (in the absence of EEG signals) to infer sleep stage. | | Use Environment | Physician office. No limitation on where data are acquired. | Physician office. No limitation on where data are acquired. | Physician office. No limitation on where data are acquired. | | Patient Population | 22 years and older | 22 years and older | 18 years and older | | Type of Use | Prescription Use only | Prescription Use only | Prescription Use only | | Signals analyzed | EEG, Chin EMG, EOG, Abdomen and Thorax RIP, SpO2, Nasal Pressure, Body position | EEG, Chin EMG, EOG Abdomen and Thorax RIP, SpO2; Cannula flow; Body position | EEG, ECG, EOG, EMG waveforms; SpO2; respiratory effort; airflow; heart/pulse rate; snoring loudness; body movement and position. | | Sleep Scoring with EEG | Automatic ready for review by medical professional | Automatic | Automatic ready for review and interpretation by a physician | | | Manual through a 3rd party application. | Manual | Manual | | Sleep Scoring Without EEG | Automatic ready for review by medical professional | Not available | Automatic ready for review and interpretation by a physician | | Score Sleep Disorder Respiratory Events | Automatic ready for review by medical professional | Automatic | Automatic ready for review and interpretation by a physician | | | Manual through a 3rd party application. | Manual | Manual | | Score Arousal Events with EEG | Automatic ready for review by medical professional | Manual | Automatic ready for review and interpretation by a physician | | | Manual through a 3rd party application. | Manual | Manual | | | | | | | Score Arousal Events without EEG | Automatic ready for review by medical professional | Not available | Automatic ready for review and interpretation by a physician | | | Automatic ready for review by medical professional | Automatic | Automatic ready for review and interpretation by a physician | | Score Body Position | Manual through a 3rd party application. | Manual | Manual | | Manual Review of Automatic Scoring | Yes | Yes…