The Circadia C300 System (C300)
Device Facts
| Record ID | K261286 |
|---|---|
| Device Name | The Circadia C300 System (C300) |
| Applicant | Circadia Health, Inc. |
| Product Code | DRT · Cardiovascular |
| Decision Date | May 20, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
Indications for Use
The Circadia C300 System is intended for the measurement of respiratory rate and heart rate, including spot measurement. The system is indicated for adult patients in clinical settings, such as skilled nursing and long-term care facilities, and in the home environment. The system is not indicated for active patient monitoring, and does not provide alarms for timely response in acute life-threatening situations. The system is not intended to monitor heart rate in patients with arrhythmias. The system is intended to be used by healthcare professionals (HCPs) and data are intended to be reviewed by HCPs to inform patient care. The system also monitors patient motion, and patient presence or absence near the device (exits).
Device Story
Contactless radar-based system; monitors respiratory rate (RR), heart rate (HR), motion, and patient presence/absence. Input: radar-detected micromotions of skin caused by ventilation and heartbeat. Operation: bedside monitor processes data continuously; streams via Wi-Fi to cloud service; retrieved by healthcare professionals (HCPs) via iOS app. Output: retrospective RR/HR data; real-time motion/presence status; notification if no HR obtained within 8 hours. Used in clinical/home settings by HCPs to inform patient care. No active monitoring or acute alarm functionality.
Clinical Evidence
No clinical data was necessary to determine substantial equivalence. Bench testing only, including IEC 60601-1-11:2015+A1:2020 testing for home healthcare environment compliance.
Technological Characteristics
Contactless radar-based monitor; 58.0-61.5 GHz FMCW radar sensor. RR range: 7-38 bpm; HR range: 40-140 bpm. Connectivity: Wi-Fi to cloud service; iOS app interface. Software: unchanged from predicate. Sterilization: N/A.
Indications for Use
Indicated for adult patients in clinical settings (skilled nursing, long-term care) and home environments for measurement of respiratory rate, heart rate, motion, and presence/absence. Not for active patient monitoring, acute life-threatening situations, or patients with arrhythmias.
Regulatory Classification
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.
Predicate Devices
- The Circadia C300 System (K252676)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 20, 2026
Circadia Health, Inc.
Erhan Ilhan
Head of Quality and Regulatory
507 S Douglas St.
El Segundo, California 90245
Re: K261286
Trade/Device Name: The Circadia C300 System (C300)
Regulation Number: 21 CFR 870.2300
Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm).
Regulatory Class: Class II
Product Code: DRT, BZQ
Dated: April 17, 2026
Received: April 20, 2026
Dear Erhan Ilhan:
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261286 - Erhan Ilhan
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(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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-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).
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K261286 - Erhan Ilhan
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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) K261286 | |
| Device Name The Circadia C300 System (C300) | |
| Indications for Use (Describe) The Circadia C300 System is intended for the measurement of respiratory rate and heart rate, including spot measurement. The system is indicated for adult patients in clinical settings, such as skilled nursing and long-term care facilities, and in the home environment. The system is not indicated for active patient monitoring, and does not provide alarms for timely response in acute life-threatening situations. The system is not intended to monitor heart rate in patients with arrhythmias. The system is intended to be used by healthcare professionals (HCPs) and data are intended to be reviewed by HCPs to inform patient care. The system also monitors patient motion, and patient presence or absence near the device (exits). | |
| 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." | |
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CIRCADIA
The Circadia C300 System
# 510(k) Summary
## 1.0 Submitter Information
Applicant Name: Circadia Health, Inc.
Applicant Address: 507 S Douglas St, El Segundo, CA 90245 USA
Applicant Contact: Erhan Ilhan
Head of Quality and Regulatory
erhan@circadia.health
(800) 985-5596
Correspondent Contact: Erhan Ilhan
Head of Quality and Regulatory
erhan@circadia.health
(800) 985-5596
Date Prepared: May 19, 2026
## 2.0 Subject Device
Trade Name: The Circadia C300 System
Common Name: Cardiac Monitor
Regulation Number: 21 CFR 870.2300
Class: II
Product Code: DRT, BZQ
Premarket Review: OPEQ/OHT2A: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
Review Panel: Cardiovascular
## 3.0 Predicate Device
Trade Name: The Circadia C300 System (K252676)
Decision Date: February 03, 2026
Common Name: Cardiac Monitor
Regulation Number: 21 CFR 870.2300
Class: II
Product Code: DRT, BZQ
Premarket Review: OPEQ/OHT2A: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
Review Panel: Cardiovascular
K261286
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CIRCADIA
The Circadia C300 System
## 4.0 Device Description
The Circadia C300 System is a contactless system that uses radar to monitor respiratory rate (RR), heart rate (HR), motion, and presence of a patient in its detection range. The System is designed to monitor a patient automatically, without the need for the patient to wear or do anything, or for a healthcare professional (HCP) to interact with the device. The System is thus suitable for long-term and unsupervised monitoring.
The System may also be used to obtain on-demand spot measurements of HR and RR. This allows HCPs to control the frequency and timing of these measurements using the Circadia C300 System.
The System consists of the Circadia Contactless Cardiorespiratory Monitor (the "Monitor"), the Circadia Cloud Service (the "Cloud Service"), and the Circadia Clinical Intelligence Platform (CIP) Application (the "App").
The Monitor may be installed next to a patient's bedside. It uses a radar-based motion sensor to detect micromotions caused by ventilation and heartbeat, to measure a patient's RR and HR while the patient is in its detection range at rest. Data is processed continuously on the Monitor, and streamed to the Cloud Service over a Wi-Fi network.
The Cloud Service offers a set of Application Programming Interfaces (APIs) that allows the Monitor to connect to the server and send data over a secure channel. In addition, it allows for patient data to be retrieved from the App.
The App allows a healthcare professional to retrospectively review RR and HR data from multiple connected Monitors. Motion and presence/exit data are available in real time. The App operates from an iOS device (not supplied, not included in the System). The App includes a functionality to notify a user if no HR has been obtained within the most recent 8 hours.
The device description is unchanged from K252676. No modifications have been made to the hardware, firmware, software, algorithm, or system architecture.
## 5.0 Indications for Use
The Circadia C300 System is intended for the measurement of respiratory rate and heart rate, including spot measurement.
The system is indicated for adult patients in clinical settings, such as skilled nursing and long-term care facilities, and in the home environment.
The system is not indicated for active patient monitoring, and does not provide alarms for timely response in acute life-threatening situations. The system is not intended to monitor heart rate in patients with arrhythmias.
The system is intended to be used by healthcare professionals (HCPs) and data are
K261286
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CIRCADIA
The Circadia C300 System
intended to be reviewed by HCPs to inform patient care.
The system also monitors patient motion, and patient presence or absence near the device (exits).
## 6.0 Comparison to Predicate Device
The subject device is substantially equivalent to the predicate device (K252676). The subject device is identical to the predicate in all technological characteristics and intended use, with the only exception of an expansion of the indications for use environment to include the home environment. This expansion is supported by updated labeling, IEC 60601-1-11 testing, updated risk management documentation, and an HF/UE analysis.
Table 6-1 compares the subject device to the predicate device.
Table 6-1: Comparison to the Predicate Device (K252676)
| Feature | Subject Device: Circadia C300 System (This Submission) | Predicate Device: Circadia C300 System | Comments |
| --- | --- | --- | --- |
| 510(k) | K261286 | K252676 | N/A |
| Decision date | N/A | February 03, 2026 | N/A |
| Product Name | Cardiac Monitor (Including Cardiotachometer And Rate Alarm) | Cardiac Monitor (Including Cardiotachometer And Rate Alarm) | Identical to Predicate |
| Product Code | DRT, BZQ | DRT, BZQ | Identical to Predicate |
| Intended Use | The intended use is to contactlessly measure heart rate and respiration rate and detect patient motion. | The intended use is to contactlessly measure heart rate and respiration rate and detect patient motion. | Identical to Predicate |
| Indications for Use | The Circadia C300 System is intended for the measurement of respiratory rate and heart rate, including spot measurement. The system is indicated for adult patients in clinical settings, such as skilled nursing and long-term care facilities, and in the home environment. | The Circadia C300 System is intended for the measurement of respiratory rate and heart rate, including spot measurement. The system is indicated for adult patients in clinical settings, such as skilled nursing and long-term care facilities. The system is not indicated for active | The only change is the addition of 'and in the home environment' to the indicated patient setting sentence. All other indications, contraindications, and limitations are identical to the predicate. |
K261286
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CIRCADIA
The Circadia C300 System
| | The system is not indicated for active patient monitoring, and does not provide alarms for timely response in acute life-threatening situations. The system is not intended to monitor heart rate in patients with arrhythmias. The system is intended to be used by healthcare professionals (HCPs) and data are intended to be reviewed by HCPs to inform patient care. The system also monitors patient motion, and patient presence or absence near the device (exits). | patient monitoring, and does not provide alarms for timely response in acute life-threatening situations. The system is not intended to monitor heart rate in patients with arrhythmias. The system is intended to be used by healthcare professionals (HCPs) and data are intended to be reviewed by HCPs to inform patient care. The system also monitors patient motion, and patient presence or absence near the device (exits). | |
| --- | --- | --- | --- |
| Patient Type | Adult | Adult | Identical to Predicate |
| User Population | Healthcare Providers | Healthcare Providers | Identical to Predicate |
| Environment | Healthcare facilities, including skilled nursing and long-term care facilities, and in the home environment. | Healthcare facilities, including skilled nursing and long-term care facilities. | The subject device adds the home environment as an indicated use setting. This is the only change from the predicate. The addition is supported by IEC 60601-1-11 testing, updated risk management, and HF/UE analysis. |
| Technology | Contactless, radar-based measurement of micro-motions | Contactless, radar-based measurement of micro-motions | Identical to Predicate |
| Physiological phenomenon measured | Micro-motions of the skin, caused by ventilation and heartbeat | Micro-motions of the skin, caused by ventilation and heartbeat | Identical to Predicate |
| Radar sensor | 58.0 - 61.5 GHz FMCW | 58.0 - 61.5 GHz FMCW | Identical to Predicate |
| Respiratory Rate Measurement Range | 7 - 38 breaths per minute | 7 - 38 breaths per minute | Identical to Predicate |
| Heart Rate Measurement | 40 - 140 beats per minute | 40 - 140 beats per minute | Identical to Predicate |
K261286
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CIRCADIA
The Circadia C300 System
| Range | | | |
| --- | --- | --- | --- |
| Detects Patient Motion, and Presence/ Absence | Yes | Yes | Identical to Predicate |
| Software | Unchanged from K252676 | Cleared under K252676 | Identical to Predicate |
7.0 Performance Data (Non-Clinical Testing)
- Home Healthcare Environment Testing (per IEC 60601-1-11:2015+A1:2020)
8.0 Performance Data (Clinical Testing)
No clinical data was necessary to determine substantial equivalence.
9.0 Warnings and Important Use Conditions
The Circadia C300 System is not intended to monitor heart rate in patients with arrhythmias, such as atrial fibrillation. Use within this patient population will likely result in reduced performance.
For optimal heart rate monitoring performance, the Circadia C300 System Monitor is intended to be used to the side of the patient, and should be positioned 1.0 meter (3.0 feet) or less from the patient.
10.0 Conclusion
The proposed Circadia C300 System is substantially equivalent to the predicate as it has the same intended use and there are no differences in technological characteristics that raise new questions of safety or effectiveness.
K261286
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