FDA Product Code DRT: Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Leading manufacturers include Sleepiz AG, Circadia Technologies, Ltd. and Circadia Health, Inc..
338
Total
338
Cleared
123d
Avg days
1976
Since
Stable submission activity - 4 submissions in the last 2 years
Consistent review times:
134d avg (recent)
FDA 510(k) Cleared Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) Devices (Product Code DRT)
338 devices
Cleared
Feb 03, 2026
The Circadia C300 System (C300)
Circadia Health, Inc.
Cardiovascular
162d
Cleared
Jan 28, 2026
Sleepiz One+ (Model 2.5)
Sleepiz AG
Cardiovascular
120d
Cleared
Jul 29, 2025
Sleepiz One+ (2.5)
Sleepiz AG
Cardiovascular
89d
Cleared
May 30, 2024
The Circadia C200 System
Circadia Technologies, Ltd.
Cardiovascular
163d
Cleared
Mar 22, 2024
Vios Monitoring System(TM) Model 2050
Murata Vios, Inc.
Cardiovascular
228d
Cleared
Feb 09, 2024
Neteera 130H-Plus Vital Sign Monitoring Sensor
Neteera Technologies , Ltd.
Cardiovascular
241d
Cleared
May 14, 2021
Cardiac Trigger Monitor
Ivy Biomedical Systems, Inc.
Cardiovascular
287d
About Product Code DRT - Regulatory Context
510(k) Submission Activity
338 total 510(k) submissions under product code DRT since 1976, with 338 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 Review Time
FDA review times for DRT submissions have been consistent, averaging 134 days recently vs 123 days historically.
DRT devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →