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..

341
Total
341
Cleared
123d
Avg days
1976
Since
Growing category - 6 submissions in the last 2 years vs 4 in the prior period
Consistent review times: 129d avg (recent)

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

341 devices
1–24 of 341
Cleared Oct 15, 2026
The Circadia CX00 System (CX00)
K262447
Circadia Health, Inc.
Cardiovascular · 91d
Cleared Sep 25, 2026
DistaSense(TM) (v1)
K254058
Life Detection Technologies
Cardiovascular · 282d
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 Oct 19, 2010
HRV ACQUIRE
K092809
Wr Medical Electronics Co.
Cardiovascular · 403d

About Product Code DRT - Regulatory Context

510(k) Submission Activity

341 total 510(k) submissions under product code DRT since 1976, with 341 receiving FDA clearance (average review time: 123 days).

Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DRT Product Code

FDA review times for DRT submissions have been consistent, averaging 129 days recently vs 123 days historically.

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