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 Nihon Kohden America, 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 Aug 04, 2006
12 RL ALGORITHM
K060307
Ge Medical Systems Information Technologies
Cardiovascular · 178d
Cleared Feb 03, 2005
TRANSMITTER, ZS-940PA SERIES
K043517
Nihon Kohden America, Inc.
Cardiovascular · 45d
Cleared Mar 03, 2004
PM-8000 PATIENT MONITOR, MODEL 8000
K032733
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 181d
Cleared Feb 15, 2002
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144
Siemens Medical Solutions USA, Inc.
Cardiovascular · 30d
Cleared Nov 15, 2001
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
K012763
Cobe Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Jan 19, 2001
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
K002061
A&D Engineering, Inc.
Cardiovascular · 197d
Cleared Jul 08, 1999
ATLAS MONITOR
K984033
Welch Allyn, Inc.
Cardiovascular · 238d
Cleared Jun 26, 1998
PASSPORT 5L-CE MODEL 0998-00-0131XXX
K974178
Datascope Corp.
Cardiovascular · 232d
Cleared Jan 13, 1998
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
K973918
Nihon Kohden America, Inc.
Cardiovascular · 90d
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
K972787
Alexander Mfg. Co.
Cardiovascular · 84d
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016
K972789
Alexander Mfg. Co.
Cardiovascular · 84d

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 →