Atlas FDA

MSX

118 FDA 510(k) clearances · Product code

98 daysmedian time to decision
266 days90th percentile
118clearances measured

FDA profile

Official device name
System, Network And Communication, Physiological Monitors
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2300
Medical specialty
Cardiovascular
Flags
Life-sustaining
Adverse events (MAUDE)
2019: 15 · 2020: 25 · 2021: 17 · 2022: 18 · 2024: 32 · 2025: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Corsano CardioWatch 287-2 System (K261367)Corsano Health B.V.2026-07-26
IntelliVue Measurement Rack 6000 (867317) (K253654)Philips Medizin Systeme Böblingen GmbH2026-03-30
TigerConnect Alarm Management (K243270)Tigerconnect2025-09-30
BeneVision Central Monitoring System (K242728)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2025-07-31
Central Station (K242750)Nihon Kohden Digital Health Solutions, LLC2025-06-05
ANNE View, Central Hub (K242842)Sibel Health, Inc.2025-01-08
Hinscope (K241397)Hinlab Sas2024-11-14
Infinity Gateway Suite (K233834)Draeger Medical Systems, Inc.2024-07-12
Biofourmis Everion+ (G2) (K233418)Biofourmis Singapore Pte., Ltd.2024-05-09
Corsano CardioWatch 287-2 System (K232548)Corsano Health B.V.2024-03-22
Current Health System (K231506)Current Health , Ltd.2023-08-24
CNS-2101 Central Monitor (K223567)Nihon Kohden Corporation2023-07-31
Everion+ System (K213863)Biofourmis Singapore Pte., Ltd.2023-02-23
Current Health System (K222550)Current Health , Ltd.2022-11-01
Infinity Gateway Suite (K203579)Draeger Medical Systems, Inc.2022-06-07
eCareManager 4.5 (K211046)Visicu, Inc.2022-06-03
BeneVision Central Monitoring System (K220058)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2022-06-01
Zyter RPM (K212622)Zyter, Inc.2022-02-11
AirStrip ONE Web Client with Alarm Communication Management (ACM) (K211949)Airstrip Technologies, Inc.2021-12-09
AlertWatch:AC (K210160)Alertwatch, Inc.2021-09-10
Current Health Monitoring System Gen 2 (G2) (K210133)Current Health2021-09-03
Aulisa Multiple Patient Digital Vital Sign Monitoring System (K202497)Taiwan Aulisa Medical Devices Technologies, Inc.2020-10-30
Smart Alarm Interface (K193421)Boxview, LLC2020-10-30
Spire Health Remote Patient Monitoring System (K192952)Spire, Inc. D/B/A Spire Health2020-06-05
BeneVision Central Monitoring System (K193391)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-05-21
Critical Alert CommonPath Enterprise (K193043)Critical Alert2020-05-11
Wearable Device, Wearable Package (K191272)Current Health , Ltd.2019-07-12
Philips IntelliVue XDS Software (K182637)Philips Medizin Systeme Boeblingen GmbH2019-04-26
Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub (K190073)Current Health , Ltd.2019-03-27
BeneVision Central Monitoring System (K183238)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2019-03-13
Digistat Smart Central (K180430)Ascom Ums Srl Unipersonale2018-11-23
Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package (K182543)Snap40, Ltd.2018-11-14
Unite Connect for Clinical Systems (K180566)Ascom Sweden AB2018-04-03
Athena GTX Device Management Suite (ADMS) Software (K173203)Athena Gtx2018-03-14
eCareManager 4.1 (K171322)Visicu, Inc.2017-08-03
BeneVision Central Monitoring System (K162607)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-04-20
eCareManager 4.0.1 (K153156)Visicu, Inc.2016-09-30
AirStrip RPM (K160862)Airstrip Technologies, Inc.2016-09-19
CareEvent inclusive of the CareEvent Mobile Application accessory (K161164)Philips Medical Systems2016-06-24
Cerner CareAware Event Management (K151672)Cerner Corporation2015-12-21
EarlySense Central Display Station (CDS) (K151006)Earlysense, Ltd.2015-08-31
Hypervisor IX Monitoring System (K150632)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-07-06
VECTRAPLEX CMS (K140852)Vectracor, Inc.2015-01-30
CareEvent (K142935)Philips Medical Systems2015-01-15
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION (K141756)Draeger Medical Systems, Inc.2014-12-12
M3290B Philips IntelliVue Information Center iX (K143057)Philips Medical Systems2014-12-03
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) (K132036)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2014-07-01
ISIRONA MAGELLAN (K130707)Isirona, LLC2013-11-20
CLINICAL ALERT NOTIFICATION (K130339)Extension , Inc.2013-07-11
ZOLL RESCUENET 12-LEAD (K121865)ZOLL Medical Corporation2012-11-20
AIRSTRIP RPM FOR LIFENET CONSULT (K121712)Airstrip Technologies, Inc.2012-11-20
EARLYSENSE CENTRAL DISPLAY SYSTEM (K121885)Earlysense, Ltd.2012-09-10
CONNEXALL SUITE OF SOFTWARE PRODUCTS (K112650)Connexall USA, Inc.2012-02-01
M VISUM ALERT ALARM MANAGEMENT SYSTEM (K112282)Mvisum, Inc.2011-11-04
ZOLL RESCUENETLINK (K111296)Zoll Medical Corporation, World Wide Headquarters2011-10-27
AMCOM COMMTECH MESSENGER (K112047)Amcom Software,Inc.2011-09-13
ASCOM MOBILE MONITORING GATEWAY (MMG) (K111215)Ascom (Sweden) AB2011-07-05
EVERON CENTRAL DISPLAY STATION (CDS) (K110521)Earlysense, Ltd.2011-04-19
ASCOM CLINICALCONNEX CARDIOMAX (K103634)Ascom (Us), Inc.2011-02-23
INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 (K102974)Philips Medical Systems2011-01-04
LIFENET SYSTEM (K102757)Physio-Control, Inc.2010-11-05
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 (K100376)Earlysense, Ltd.2010-08-06
LIFENET SYSTEM (K093925)Physio-Control, Inc.2010-01-12
PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 (K091176)Philips Medical Systems2009-11-13
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) (K080192)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2008-04-03
PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 (K071391)Philips Medical Systems, Inc.2007-09-07
MASIMO PATIENT SAFETY NET (K071047)Masimo Corporation2007-06-08
LINK TO ACUITY CLINICIAN NOTIFIER (K070204)Welch Allyn Protocol, Inc.2007-03-23
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 (K070421)GE Healthcare2007-03-13
PMP4 APPLICATION (K061428)Card Guard Scientific Survival , Ltd.2006-10-16
SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 (K062278)Spacelabs Medical, Inc.2006-09-19
BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE (K061932)Cardiopulmonary Corp.2006-09-14
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE (K061994)GE Healthcare2006-08-11
MODIFICATION TO INFINITY EXPLORER (K060254)Draeger Medical Systems, Inc.2006-04-04
DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE (K052975)GE Healthcare2006-01-20
LIFENET EXCHANGE SYSTEM (K052854)Medtronic Emergency Response Systems, Inc.2006-01-20
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 (K052972)GE Healthcare2005-12-29
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION (K051634)GE Healthcare2005-07-19
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE (K051283)Cardiopulmonary Corp.2005-06-23
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS (K042845)Philips Medizin Systeme Boblingen GmbH2004-11-12
GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 (K042771)Datex-Ohmeda2004-10-15
MODIFICATION TO INFINITY EXPLORER (K040945)Draeger Medical Systems, Inc.2004-05-12
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE (K033281)Datex-Ohmeda2003-11-26
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE (K033078)Datex-Ohmeda2003-10-29
UNITY NETWORK PATIENT DATA SERVER (K032582)Ge Medical Systems Information Technologies2003-09-17
UNITY NETWORK IS PATIENT VIEWER (K032346)Ge Medical Systems Information Technologies2003-08-05
INFINITY EXPLORER (K030615)Siemens Medical Solutions USA, Inc.2003-03-21
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE (K023497)Datex-Ohmeda2002-11-04
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02 (K022507)Datex-Ohmeda2002-08-23
UNITY IS PATIENT VIEWER (K020661)General Electric Medical Systems Information Techn2002-05-24
PATIENTNET MONITORING SYSTEM (K020524)General Electric Medical Systems Information Techn2002-03-20
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE (K020018)Cardiopulmonary Corp.2002-02-21
DATEX-OHMEDA S/5 WEB VIEWER (K013387)Datex-Ohmeda2002-01-08
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 (K013246)Datex-Ohmeda2001-12-11
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX (K012531)Datex-Ohmeda2001-11-02
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM (K013156)Data Critical Corp.2001-10-19
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM (K012005)Data Critical Corp.2001-07-24
MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS (K012171)Visicu, Inc.2001-07-24
MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM (K011999)Data Critical Corp.2001-07-24
ALARMVIEW WIRELESS DATA NETWORK SYSTEM (K010912)Data Critical Corp.2001-04-05
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