The Circadia C300 System (C300)
FDA 510(k) K261286 · Circadia Health, Inc.
510(k) numberK261286
Submission
- Device name
- The Circadia C300 System (C300)
- Applicant
- Circadia Health, Inc.
El Segundo, CA, US - Received
- April 20, 2026
- Decision date
- May 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code DRT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252676 | The Circadia C300 System (C300)DRT · Traditional | Circadia Health, Inc. | 02/03/2026SE |
| K253388 | Sleepiz One+ (Model 2.5)DRT · Special | Sleepiz AG | 01/28/2026SE |
| K251364 | Sleepiz One+ (2.5)DRT · Special | Sleepiz AG | 07/29/2025SE |
| K234003 | The Circadia C200 SystemDRT · Traditional | Circadia Technologies, Ltd. | 05/30/2024SE |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server…DRT · Traditional | Murata Vios, Inc. | 03/22/2024SE |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 02/09/2024SE |
| K223163 | Sleepiz One+DRT · Traditional | Sleepiz AG | 08/18/2023SE |
| K212143 | Neteera 130H/131H Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 09/28/2022SE |
| K202138 | Cardiac Trigger MonitorDRT · Traditional | Ivy Biomedical Systems, Inc. | 05/14/2021SE |
| K202464 | Vital Sign Monitoring Sensor (Model :XK300)DRT · Traditional | Xandar Kardian, Inc. | 04/26/2021SE |
More from Xandar Kardian, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252676 | The Circadia C300 System (C300)DRT · Traditional | 02/03/2026SE |
Questions and answers
When was The Circadia C300 System (C300) cleared by the FDA?
The Circadia C300 System (C300) (K261286) received a 510(k) decision of Substantially Equivalent on May 20, 2026, 30 days after the submission was received.
What is the product code of K261286?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.