ClearanceBrief
Panels › Cardiovascular › Product code DRT · Class 2

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Regulation 870.2300

5510(k)s in 12 months (341 all time)
0recalls in 12 months (11 all time)
10recalls that name a 510(k)
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Top companies in DRT

Company510(k)sRecalls
Hewlett-Packard Co.200
Litton Medical Electronics170
Datascope Corp.75
Ivy Biomedical Systems, Inc.100
Life Science Instrumentation, Inc.100
Nihon Kohden America, Inc.100
S & W Medico Teknik80
Ge Medical Systems Information Technologies60
Honeywell, Inc.60
Rigel Medical Electronics, Inc.60
Decided510(k)Device and applicantCode
Oct 15, 2026K262447The Circadia CX00 System (CX00)
Circadia Health, Inc.
DRT
Sep 25, 2026K254058DistaSense(TM) (v1)
Life Detection Technologies
DRT
May 20, 2026K261286The Circadia C300 System (C300)
Circadia Health, Inc.
DRT
Feb 3, 2026K252676The Circadia C300 System (C300)
Circadia Health, Inc.
DRT
Jan 28, 2026K253388Sleepiz One+ (Model 2.5)
Sleepiz AG, CH
DRT
Jul 29, 2025K251364Sleepiz One+ (2.5)
Sleepiz AG, CH
DRT
May 30, 2024K234003The Circadia C200 System
Circadia Technologies, Ltd., GB
DRT
Mar 22, 2024K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
Murata Vios, Inc.
DRT
Feb 9, 2024K231733Neteera 130H-Plus Vital Sign Monitoring Sensor
Neteera Technologies , Ltd., IL
DRT
Aug 18, 2023K223163Sleepiz One+
Sleepiz AG, CH
DRT
Sep 28, 2022K212143Neteera 130H/131H Vital Sign Monitoring Sensor
Neteera Technologies , Ltd., IL
DRT
May 14, 2021K202138Cardiac Trigger Monitor
Ivy Biomedical Systems, Inc.
DRT
Apr 26, 2021K202464Vital Sign Monitoring Sensor (Model :XK300)
Xandar Kardian, Inc., KR
DRT
Mar 7, 2019K181165Philips wearable biosensor-G5 Solution
Connected Sensing- A Division of Philips Medical Systems
DRT
Jun 22, 2018K172586Vios Monitoring System™ Model 2050
Vios Medical, Inc.
DRT
May 17, 2017K170828Cardiac Trigger Monitor
Ivy Biomedical Systems, Inc.
DRT
May 27, 2016K151781Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
Ivy Biomedical Systems, Inc.
DRT
Dec 16, 2015K150992Vios Monitoring System
Vios Medical, Inc.
DRT
Jan 25, 2013K121860ESA615
Fluke Biomedical
DRT
Oct 11, 2012K121722ESA620 ELECTRICAL SAFETY ANALYZER
Fluke Biomedical
DRT
Sep 2, 2011K110429PROSIM 4, PROSIM 6, PROSIM 8
Fluke Biomedical
DRT
Jul 22, 2011K110987CARDIAC TRIGGER MONITOR
Ivy Biomedical Systems, Inc.
DRT
Apr 13, 2011K103336MPS450 MULTIPARAMETER SIMULATOR
Fluke Biomedical
DRT
Oct 19, 2010K092809HRV ACQUIRE
Wr Medical Electronics Co.
DRT
Sep 15, 2010K102174ZOLL PROPAQ M
Zoll Medical Corporation, World Wide Headquarters
DRT
Apr 15, 2010K100745LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
Hoana Medical, Inc.
DRT
Oct 2, 2009K092037LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM
Hoana Medical, Inc.
DRT
Jul 24, 2009K091985UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
Ivy Biomedical Systems, Inc.
DRT
May 27, 2009K091050506CN PATIENT MONITOR
Criticare Systems, Inc.
DRT
Apr 13, 2009K083534LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
Hoana Medical, Inc.
DRT
Feb 13, 2009K083854CARDIAC TRIGGER, MODEL: CTM300
Ivy Biomedical Systems, Inc.
DRT
Jan 16, 2009K082626PAM 3000
Wireless 2000 RF & Uwb Technologies , Ltd., CA
DRT
Sep 26, 2008K082366LIFEBED PATIENT VIGILANCE SYSTEM
Hoana Medical, Inc.
DRT
Sep 19, 2007K063735PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112
Presym, Inc.
DRT
Aug 4, 2006K06030712 RL ALGORITHM
Ge Medical Systems Information Technologies
DRT
Feb 2, 2006K052446LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM
Hoana Medical, Inc.
DRT
Aug 12, 2005K051038506 PATIENT MONITOR
Ciriticare Systems, Inc.
DRT
Mar 1, 2005K033646TRIFIT 700
Healthfirst Corp.
DRT
Feb 3, 2005K043517TRANSMITTER, ZS-940PA SERIES
Nihon Kohden America, Inc.
DRT
Jan 10, 2005K043354MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
Invivo Research, Inc.
DRT
Mar 3, 2004K032733PM-8000 PATIENT MONITOR, MODEL 8000
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
DRT
Apr 8, 2003K030656ENVAN HEART RATE MONITOR
Envan, LLC
DRT
Nov 4, 2002K023616PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
Ivy Biomedical Systems, Inc.
DRT
Aug 14, 2002K022435507EL VITAL SIGNS MONITOR
Criticare Systems, Inc.
DRT
Jul 23, 2002K021681MICROPAQ, MODELS 402, 404
Welch Allyn Protocol, Inc.
DRT
Feb 15, 2002K020144SIEMENS INFINITY SC 6002XL MODIFICATIONS
Siemens Medical Solutions USA, Inc.
DRT
Nov 15, 2001K012763SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
Cobe Cardiovascular, Inc.
DRT
Aug 20, 2001K012451PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246
Welch Allyn Protocol, Inc.
DRT
May 16, 2001K010587ACTIVEECG
Active Corp.
DRT
Jan 19, 2001K002061A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
A&D Engineering, Inc.
DRT

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