Atlas FDA

DRT

339 FDA 510(k) clearances · Product code

90 daysmedian time to decision
262 days90th percentile
339clearances measured

FDA profile

Official device name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2300
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 85 · 2022: 35 · 2023: 47 · 2024: 29 · 2025: 40 · 2026: 35
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
The Circadia C300 System (C300) (K261286)Circadia Health, Inc.2026-05-20
The Circadia C300 System (C300) (K252676)Circadia Health, Inc.2026-02-03
Sleepiz One+ (Model 2.5) (K253388)Sleepiz AG2026-01-28
Sleepiz One+ (2.5) (K251364)Sleepiz AG2025-07-29
The Circadia C200 System (K234003)Circadia Technologies, Ltd.2024-05-30
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software (K232354)Murata Vios, Inc.2024-03-22
Neteera 130H-Plus Vital Sign Monitoring Sensor (K231733)Neteera Technologies , Ltd.2024-02-09
Sleepiz One+ (K223163)Sleepiz AG2023-08-18
Neteera 130H/131H Vital Sign Monitoring Sensor (K212143)Neteera Technologies , Ltd.2022-09-28
Cardiac Trigger Monitor (K202138)Ivy Biomedical Systems, Inc.2021-05-14
Vital Sign Monitoring Sensor (Model :XK300) (K202464)Xandar Kardian, Inc.2021-04-26
Philips wearable biosensor-G5 Solution (K181165)Connected Sensing- A Division of Philips Medical Systems2019-03-07
Vios Monitoring Systemâ„¢ Model 2050 (K172586)Vios Medical, Inc.2018-06-22
Cardiac Trigger Monitor (K170828)Ivy Biomedical Systems, Inc.2017-05-17
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor (K151781)Ivy Biomedical Systems, Inc.2016-05-27
Vios Monitoring System (K150992)Vios Medical, Inc.2015-12-16
ESA615 (K121860)Fluke Biomedical2013-01-25
ESA620 ELECTRICAL SAFETY ANALYZER (K121722)Fluke Biomedical2012-10-11
PROSIM 4, PROSIM 6, PROSIM 8 (K110429)Fluke Biomedical2011-09-02
CARDIAC TRIGGER MONITOR (K110987)Ivy Biomedical Systems, Inc.2011-07-22
MPS450 MULTIPARAMETER SIMULATOR (K103336)Fluke Biomedical2011-04-13
HRV ACQUIRE (K092809)Wr Medical Electronics Co.2010-10-19
ZOLL PROPAQ M (K102174)Zoll Medical Corporation, World Wide Headquarters2010-09-15
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM (K100745)Hoana Medical, Inc.2010-04-15
LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM (K092037)Hoana Medical, Inc.2009-10-02
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE (K091985)Ivy Biomedical Systems, Inc.2009-07-24
506CN PATIENT MONITOR (K091050)Criticare Systems, Inc.2009-05-27
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM (K083534)Hoana Medical, Inc.2009-04-13
CARDIAC TRIGGER, MODEL: CTM300 (K083854)Ivy Biomedical Systems, Inc.2009-02-13
PAM 3000 (K082626)Wireless 2000 RF & Uwb Technologies , Ltd.2009-01-16
LIFEBED PATIENT VIGILANCE SYSTEM (K082366)Hoana Medical, Inc.2008-09-26
PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 (K063735)Presym, Inc.2007-09-19
12 RL ALGORITHM (K060307)Ge Medical Systems Information Technologies2006-08-04
LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM (K052446)Hoana Medical, Inc.2006-02-02
506 PATIENT MONITOR (K051038)Ciriticare Systems, Inc.2005-08-12
TRIFIT 700 (K033646)Healthfirst Corp.2005-03-01
TRANSMITTER, ZS-940PA SERIES (K043517)Nihon Kohden America, Inc.2005-02-03
MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 (K043354)Invivo Research, Inc.2005-01-10
PM-8000 PATIENT MONITOR, MODEL 8000 (K032733)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2004-03-03
ENVAN HEART RATE MONITOR (K030656)Envan, LLC2003-04-08
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) (K023616)Ivy Biomedical Systems, Inc.2002-11-04
507EL VITAL SIGNS MONITOR (K022435)Criticare Systems, Inc.2002-08-14
MICROPAQ, MODELS 402, 404 (K021681)Welch Allyn Protocol, Inc.2002-07-23
SIEMENS INFINITY SC 6002XL MODIFICATIONS (K020144)Siemens Medical Solutions USA, Inc.2002-02-15
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM (K012763)Cobe Cardiovascular, Inc.2001-11-15
PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 (K012451)Welch Allyn Protocol, Inc.2001-08-20
ACTIVEECG (K010587)Active Corp.2001-05-16
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR (K002061)A&D Engineering, Inc.2001-01-19
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM (K001775)Zoe Medical, Inc.2001-01-12
MICROPAQ, MODELS 402 AND 404 (K002725)Protocol Systems, Inc.2000-11-21
ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR (K992413)Medical Data Electronics1999-08-19
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR (K992411)Medical Data Electronics1999-08-18
ATLAS MONITOR (K984033)Welch Allyn, Inc.1999-07-08
DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 (K981378)Datex-Engstrom, Inc.1998-11-03
MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT (K974581)Invivo Research, Inc.1998-10-28
PASSPORT 5L-CE MODEL 0998-00-0131XXX (K974178)Datascope Corp.1998-06-26
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES (K973918)Nihon Kohden America, Inc.1998-01-13
HEART PROTECTOR (VER 1996) (K965158)N.P.N.T., Inc.1997-12-09
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016 (K972789)Alexander Mfg. Co.1997-10-17
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P (K972787)Alexander Mfg. Co.1997-10-17
MOBILE MEDICAL MONITOR (M3(A)) (K963576)Scientific Applications1997-02-28
LOG-A-RYTHM MODEL 100 AND MODEL 1001 (K952790)Nian-Crae, Inc.1996-10-17
CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM (K960544)Nasiff Assoc., Inc.1996-08-07
OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM (K950688)Safety Tek Corp.1996-04-18
EAGLE 3000 PATIENT MONITOR (K952474)Marquette Electronics, Inc.1995-10-19
RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR (K941252)Ansar1995-09-20
ECG MONITOR (K944262)Fukuda Denshi USA, Inc.1995-05-12
PROPAQ 200 MONITOR (K945071)Protocol Systems, Inc.1995-05-10
MERCURY (K940081)Mennen Medical, Inc.1995-04-12
PULSE HEART RATE MONITOR (K943243)Sensor Dynamics, Inc.1995-03-10
PRO-SPORT HEART RATE MONITOR (K943242)Sensor Dynamics, Inc.1995-03-10
K3 SYSTEM (K934644)Astro-Med, Inc.1994-11-01
PAM CARDIAC MONITOR (K934684)Technology Transfer, Inc.1994-10-17
LIONHEART 3 MULTI-PARAMETER SIMULATOR (K944257)Bio-Tek Instruments, Inc.1994-09-21
OMNI-CENTRAL STATION MONITOR (K936051)Invivo Research, Inc.1994-07-06
520 DISPLAY DRIVER- STATUS I (K926298)Vidco, Inc.1994-05-04
MEDSIM 300 PATIENT SIMULATOR (K935817)Dynatech/Nevada, Inc.1994-01-18
ESCORT 100/300 SERIES B PATIENT MONITORS (K930004)Medical Data Electronics1993-06-23
SYSTEM ATHENA, MODIFICATION (K911611)S & W Medico Teknik1993-02-05
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING (K921194)Hewlett-Packard Co.1992-11-09
MODIFIED BIOLOG (K915624)Micromedical Industries, Ltd.1992-03-27
GYMMAN (K920099)Lumiscope Co., Inc.1992-03-09
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED (K910665)Ge Medical Systems Information Technologies1991-12-31
KELLER CARDIAC MONITOR MEDIL KMS870 (K914576)Keller Medical Specialties Products, Inc.1991-12-30
SYSTEM ATHENA - PRODUCT ENHANCEMENTS (K912049)S & W Medico Teknik1991-12-05
DATASCOPE PASSPORT MONITOR (K911598)Datascope Corp.1991-10-15
TRU-VIEW MULTI-CHANNEL DISPLAY (K912008)General Devices1991-10-09
EDENTEC MODEL 3711 DIGITAL RECORDER (K910870)Edentec Corp.1991-08-29
507 NON-INVASIVE VITAL SIGNS MONITOR (K910852)Criticare Systems, Inc.1991-07-30
FUTURECARE CARELYNK IV SYSTEM (K903512)Futurecare Systems, Inc.1991-07-18
VITALMAX 2100/2200 (K905274)Pace Tech, Inc.1991-07-17
HORIZON XL (K911616)Mennen Medical, Inc.1991-07-10
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A (K911139)Hewlett-Packard Co.1991-06-11
PROPAQ 102EL, 104EL AND 106EL (K910882)Protocol Systems, Inc.1991-05-08
WEP-8430A TELEMETRY CENTRAL STATION (K904696)Nihon Kohden America, Inc.1991-02-07
CARDIOMATIC MODEL MSC-2001 (K904353)Medical Systems Corp.1990-12-20
MORTARA INSTRUMENT MODEL ELI 50 (K902652)Mortara Instrument, Inc.1990-08-23
VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE (K900451)Pace Tech, Inc.1990-07-18
CARDIOMATIC MODEL MSC-1001 (K902608)Medical Systems Corp.1990-07-13
PCI MODEL 2041-PC TELEMETRY MONITOR (K901031)Accucore, Inc.1990-05-17
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