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DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K252676circadia healthThe Circadia C300 System (C300)February 3, 2026
K253388sleepizSleepiz One+ (Model 2.5)January 28, 2026
K251364sleepizSleepiz One+ (2.5)July 29, 2025
K234003circadia technologiesThe Circadia C200 SystemMay 30, 2024
K232354murata viosVios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios CentralMarch 22, 2024
K231733neteera technologiesNeteera 130H-Plus Vital Sign Monitoring SensorFebruary 9, 2024
K223163sleepizSleepiz One+August 18, 2023
K212143neteera technologiesNeteera 130H/131H Vital Sign Monitoring SensorSeptember 28, 2022
K202138ivy biomedical systemsCardiac Trigger MonitorMay 14, 2021
K202464xandar kardianVital Sign Monitoring Sensor (Model :XK300)April 26, 2021
K181165connected sensing- a division of philips medical systemsPhilips wearable biosensor-G5 SolutionMarch 7, 2019
K172586vios medicalVios Monitoring System™ Model 2050June 22, 2018
K170828ivy biomedical systemsCardiac Trigger MonitorMay 17, 2017
K151781ivy biomedical systemsCardiac Trigger Monitor, Cardiac & Regulatory Synchronization MonitorMay 27, 2016
K150992vios medicalVios Monitoring SystemDecember 16, 2015
K121860fluke biomedicalESA615January 25, 2013
K121722fluke biomedicalESA620 ELECTRICAL SAFETY ANALYZEROctober 11, 2012
K110429fluke biomedicalPROSIM 4, PROSIM 6, PROSIM 8September 2, 2011
K110987ivy biomedical systemsCARDIAC TRIGGER MONITORJuly 22, 2011
K103336fluke biomedicalMPS450 MULTIPARAMETER SIMULATORApril 13, 2011