DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class II
FDA product code DRT covers "Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)", a Class II medical device regulated under 21 CFR 870.2300. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRT
- Device Class
- Class II
- Regulation Number
- 870.2300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261286 | circadia health | The Circadia C300 System (C300) | May 20, 2026 |
| K252676 | circadia health | The Circadia C300 System (C300) | February 3, 2026 |
| K253388 | sleepiz | Sleepiz One+ (Model 2.5) | January 28, 2026 |
| K251364 | sleepiz | Sleepiz One+ (2.5) | July 29, 2025 |
| K234003 | circadia technologies | The Circadia C200 System | May 30, 2024 |
| K232354 | murata vios | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central | March 22, 2024 |
| K231733 | neteera technologies | Neteera 130H-Plus Vital Sign Monitoring Sensor | February 9, 2024 |
| K223163 | sleepiz | Sleepiz One+ | August 18, 2023 |
| K212143 | neteera technologies | Neteera 130H/131H Vital Sign Monitoring Sensor | September 28, 2022 |
| K202138 | ivy biomedical systems | Cardiac Trigger Monitor | May 14, 2021 |
| K202464 | xandar kardian | Vital Sign Monitoring Sensor (Model :XK300) | April 26, 2021 |
| K181165 | connected sensing- a division of philips medical systems | Philips wearable biosensor-G5 Solution | March 7, 2019 |
| K172586 | vios medical | Vios Monitoring System Model 2050 | June 22, 2018 |
| K170828 | ivy biomedical systems | Cardiac Trigger Monitor | May 17, 2017 |
| K151781 | ivy biomedical systems | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | May 27, 2016 |
| K150992 | vios medical | Vios Monitoring System | December 16, 2015 |
| K121860 | fluke biomedical | ESA615 | January 25, 2013 |
| K121722 | fluke biomedical | ESA620 ELECTRICAL SAFETY ANALYZER | October 11, 2012 |
| K110429 | fluke biomedical | PROSIM 4, PROSIM 6, PROSIM 8 | September 2, 2011 |
| K110987 | ivy biomedical systems | CARDIAC TRIGGER MONITOR | July 22, 2011 |