DRT · Class II · 21 CFR 870.2300

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

Leading manufacturers include Hewlett-Packard Co., Abbott Laboratories and Siemens Medical Solutions USA, 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 Feb 15, 2002
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144
Siemens Medical Solutions USA, Inc.
Cardiovascular · 30d
Cleared Nov 09, 1992
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
K921194
Hewlett-Packard Co.
Cardiovascular · 242d
Cleared Jun 11, 1991
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
K911139
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Apr 10, 1990
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032
Hewlett-Packard Co.
Cardiovascular · 98d
Cleared Mar 11, 1986
SIRECUST 341 AND 341R
K854881
Siemens Medical Solutions USA, Inc.
Cardiovascular · 95d
Cleared Jun 06, 1985
MODEL 78353B
K842817
Hewlett-Packard Co.
Cardiovascular · 323d
Cleared Apr 11, 1985
SIEMENS SIRECUST 404N NEONATAL MONITOR
K844187
Siemens Medical Solutions USA, Inc.
Cardiovascular · 164d
Cleared Jan 18, 1985
PATIENT MONITOR 78354A
K842236
Hewlett-Packard Co.
Cardiovascular · 227d
Cleared Feb 27, 1984
PATIENT MONITOR 78534B
K840251
Hewlett-Packard Co.
Cardiovascular · 54d
Cleared Oct 19, 1983
PATIENT MONITOR 788 33A
K831943
Hewlett-Packard Co.
Cardiovascular · 125d
Cleared Oct 19, 1983
PATIENT MONITOR #78832A
K831944
Hewlett-Packard Co.
Cardiovascular · 125d

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 →