DRT · Class II · 21 CFR 870.2300

FDA Product Code DRT: Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

Leading manufacturers include Hewlett-Packard Co., Litton Medical Electronics and Ivy Biomedical Systems, Inc..

339
Total
339
Cleared
123d
Avg days
1976
Since
Stable submission activity - 4 submissions in the last 2 years
Review times improving: avg 100d recently vs 123d historically

FDA 510(k) Cleared Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) Devices (Product Code DRT)

339 devices
1–24 of 339
Cleared May 20, 2026
The Circadia C300 System (C300)
K261286
Circadia Health, Inc.
Cardiovascular · 30d
Cleared Feb 03, 2026
The Circadia C300 System (C300)
K252676
Circadia Health, Inc.
Cardiovascular · 162d
Cleared Jan 28, 2026
Sleepiz One+ (Model 2.5)
K253388
Sleepiz AG
Cardiovascular · 120d
Cleared Jul 29, 2025
Sleepiz One+ (2.5)
K251364
Sleepiz AG
Cardiovascular · 89d
Cleared May 30, 2024
The Circadia C200 System
K234003
Circadia Technologies, Ltd.
Cardiovascular · 163d
Cleared Mar 22, 2024
Vios Monitoring System(TM) Model 2050
K232354
Murata Vios, Inc.
Cardiovascular · 228d
Cleared Feb 09, 2024
Neteera 130H-Plus Vital Sign Monitoring Sensor
K231733
Neteera Technologies , Ltd.
Cardiovascular · 241d
Cleared Aug 18, 2023
Sleepiz One+
K223163
Sleepiz AG
Cardiovascular · 315d
Cleared Sep 28, 2022
Neteera 130H/131H Vital Sign Monitoring Sensor
K212143
Neteera Technologies , Ltd.
Cardiovascular · 446d
Cleared May 14, 2021
Cardiac Trigger Monitor
K202138
Ivy Biomedical Systems, Inc.
Cardiovascular · 287d
Cleared Apr 26, 2021
Vital Sign Monitoring Sensor (Model :XK300)
K202464
Xandar Kardian, Inc.
Cardiovascular · 242d
Cleared Mar 07, 2019
Philips wearable biosensor-G5 Solution
K181165
Connected Sensing- A Division of Philips Medical Systems
Cardiovascular · 309d
Cleared Jun 22, 2018
Vios Monitoring System™ Model 2050
K172586
Vios Medical, Inc.
Cardiovascular · 298d
Cleared May 17, 2017
Cardiac Trigger Monitor
K170828
Ivy Biomedical Systems, Inc.
Cardiovascular · 58d
Cleared May 27, 2016
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
K151781
Ivy Biomedical Systems, Inc.
Cardiovascular · 331d
Cleared Dec 16, 2015
Vios Monitoring System
K150992
Vios Medical, Inc.
Cardiovascular · 245d
Cleared Jan 25, 2013
ESA615
K121860
Fluke Biomedical
Cardiovascular · 213d
Cleared Oct 11, 2012
ESA620 ELECTRICAL SAFETY ANALYZER
K121722
Fluke Biomedical
Cardiovascular · 121d
Cleared Sep 02, 2011
PROSIM 4, PROSIM 6, PROSIM 8
K110429
Fluke Biomedical
Cardiovascular · 199d
Cleared Jul 22, 2011
CARDIAC TRIGGER MONITOR
K110987
Ivy Biomedical Systems, Inc.
Cardiovascular · 105d
Cleared Apr 13, 2011
MPS450 MULTIPARAMETER SIMULATOR
K103336
Fluke Biomedical
Cardiovascular · 149d
Cleared Sep 15, 2010
ZOLL PROPAQ M
K102174
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 44d
Cleared Jul 24, 2009
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
K091985
Ivy Biomedical Systems, Inc.
Cardiovascular · 22d
Cleared May 27, 2009
506CN PATIENT MONITOR
K091050
Criticare Systems, Inc.
Cardiovascular · 44d

About Product Code DRT - Regulatory Context

510(k) Submission Activity

339 total 510(k) submissions under product code DRT since 1976, with 339 receiving FDA clearance (average review time: 123 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - DRT Product Code

Recent submissions under DRT have taken an average of 100 days to reach a decision - down from 123 days historically, suggesting improved FDA processing for this classification.

DRT devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →