Atlas FDA

HGM

214 FDA 510(k) clearances · Product code

93 daysmedian time to decision
328 days90th percentile
214clearances measured

FDA profile

Official device name
System, Monitoring, Perinatal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2740
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 71 · 2022: 87 · 2023: 69 · 2024: 174 · 2025: 101 · 2026: 65
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ANNE Maternal (K253021)Sibel Health, Inc.2026-02-26
Sonicaid Team3 (K250777)Huntleigh Healthcare , Ltd.2025-09-19
Fetal & Maternal Monitor (F15A, F15A Air) (K241882)Edan Instruments, Inc.2025-08-27
Sonicaid Team3 (K241368)Huntleigh Healthcare , Ltd.2025-02-03
PeriCALM Patterns 3.0 (K241009)Perigen, Inc.2025-01-10
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) (K233440)Philips Medizin Systeme Boeblingen GmbH2024-07-02
Novii+ Wireless Patch System (K231964)Datex Ohmeda2023-12-08
Bloomlife MFM-Pro (K222327)Bloom Technologies NV2023-02-13
Mural Perinatal Surveillance (K220732)Ge Medical Systems Information Technologies, Inc.2022-06-23
Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (K200975)Huntleigh Healthcare Limited2020-06-24
IntelliSpace Perinatal Rev.K.00 (K173941)Philips Medizin Systeme Boeblingen GmbH2018-09-10
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 (K173042)Edan Instruments, Inc.2018-08-30
AlertWatch:OB (K173715)Alertwatch, Inc.2018-04-23
Central Monitoring System (K171178)Edan Instruments, Inc.2017-09-06
F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring (K171865)Farus, LLC2017-08-24
Meridian M110 Fetal Monitoring System (K161902)Mindchild Medical2017-01-12
Central Monitoring System (K153580)Guangdong Biolight Meditech Co., Ltd.2016-09-07
EUM 100Pro (K150398)Ob Tools, Ltd.2015-08-06
Model BT-220L and BT-220C (K142799)Bistos Co., Ltd.2015-07-09
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express (K150901)Edan Instruments, Inc.2015-07-01
MindChild Meridian M100 Fetal Heart Rate Monitor (K142883)Mindchild Medical2015-04-17
CENTRAL MONITORING SYSTEM (K143695)Edan Instruments, Inc.2015-03-30
PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 (K140535)Philips Medizin Systeme Boblingen GmbH2014-11-25
FM-3000 FETAL MONITOR (K141194)Advanced Instrumentations, Inc.2014-11-19
FETAL MONITORS (K131941)Guangdong Biolight Meditech Co., Ltd.2014-05-15
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM (K132650)Huntleigh Healthcare Limited2014-02-07
SENSE-4BABY SYSTEM (K132918)Sense4baby , Inc.2013-11-22
SUNRAY FETAL MONITOR (K123335)Sunray Medical Apparatus Co., Ltd.2013-03-21
CERNER FETALINK+(VERSION1.0) (K121758)Cerner Corp.2012-10-09
MINDCHILD MERIDIAN FETAL HEART RATE MONITOR (K120018)Mindchild Medical2012-09-19
BT-200V VASCULAR DOPPLER (K121267)Bistos Co., Ltd.2012-08-02
OBIX PERINATAL DATA SYSTEM 7.0 (K121208)Clinical Computer Systems, Inc.2012-06-14
FM-9000 PLUS FETAL AND MATERNAL MONITOR (K112317)Advanced Instrumentations, Inc.2011-12-21
FM20 (K110612)Mediana Co., Ltd.2011-11-08
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE (K111614)Ge Healthcare Integrated IT Solutions2011-09-26
FM-1000 PLUS FETAL MONITOR (K112187)Advanced Instrumentations, Inc.2011-09-21
CMS-1000FM CENTRAL MONITORING SYSTEM (K112159)Advanced Instrumentations, Inc.2011-09-21
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 (K111083)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011-08-17
MINI TELEMETRY SYSTEM (K110556)Wipro GE Healthcare Private, Ltd.2011-07-19
BT-350 (K103545)Bistos Co., Ltd.2011-05-13
HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 (K102263)Mckesson Information Solutions, LLC2011-05-05
PHILIPS AVALON FETAL MONITOR (K102958)Philips Medizin Systeme Boblingen GmbH2011-03-18
CIV-OB (PLUS) (K103172)Civnet Communication, Ltd.2011-03-11
FETAL MONITORS, MODELS F2 AND F3 (K102140)Edan Instruments, Inc.2011-01-13
CENTRAL MONITORING SYSTEM (K100358)Edan Instruments, Inc.2011-01-06
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS (K100797)Edan Instruments, Inc.2010-11-10
PHILIPS OBTRACEVUE MODEL SW REV. G.00 (K100420)Philips Medizin Systeme Boeblingen GmbH2010-07-26
FETAL MONITOR MODEL: BT-200T (K100885)Bistos Co., Ltd.2010-06-07
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 (K092028)Philips Medizin Systeme Boeblingen GmbH2010-02-17
CERNER FETALINK (VERSION 1.0) (K091251)Cerner Corp.2009-08-25
SONICAID FM820 AND FM830 ENCORE (K090285)Huntleigh Healthcare , Ltd.2009-07-15
AIRSTRIP OB (K090269)Airstrip Technologies, LP2009-02-13
AIRSTRIP OB (K090061)Airstrip Technologies, LP2009-01-23
FETAL & MATERNAL MONITOR, MODEL F6, F9 (K082602)Edan Instruments, Inc.2008-11-26
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR (K082369)Edan Instruments, Inc.2008-11-07
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 (K081203)Philips Medizin Systeme Boeblingen GmbH2008-05-28
NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 (K080226)Hill-Rom Manufacturing, Inc.2008-04-09
CADENCE II (K073221)Edan Instruments, Inc.2007-12-28
MODEL 250CX SERIES MATERNAL/FETAL MONITOR (K072976)GE Healthcare2007-12-20
PHILIPS AVALON FETAL MONITORS FM20 AND FM30 (K071800)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007-09-27
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 (K062137)Philips Medizin Systeme Boeblingen GmbH2006-08-24
FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS (K050826)Cetro America2006-04-10
DOPPLEX CENTRALE (K060230)Huntleigh Healthcare , Ltd.2006-03-23
CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION (K051175)Civent Communications, Ltd.2006-02-17
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 (K052795)Philips Medizin Systeme Boeblingen GmbH2005-12-30
CALM CURVE, VERSION 01.00 (K052715)Lms Medical Systems (Canada), Ltd.2005-12-22
FC 700 FETAL MONITOR (K043597)Bionet Co., Ltd.2005-12-16
FC 1400 FETAL MONITOR (K043598)Bionet Co., Ltd.2005-12-16
FETAL MONITOR, MODELS BT-300 AND BT-200 (K052190)Bistos Co., Ltd.2005-10-04
REMOTE CARE (K050234)E.Care Solutions, Inc.2005-08-25
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING (K043075)Tenacore Holdings, Inc.2005-08-18
MODEL 250 SERIES MATERNAL/FETAL MONITOR (K050583)Ge Medical Systems Information Technologies2005-06-21
CALM PATTERNS, VERSION 01.00.00 (K040788)Lms Medical Systems , Ltd.2005-02-08
AIRSTRIP OB (K042082)Mp4 Solutions, LP2005-01-21
CADENCE, MODELS 2001 AND 2002 (K040903)Edan Instruments, Inc.2004-09-02
TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 (K040819)American I.V. Products, Inc.2004-08-16
MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM (K032772)Hill-Rom Manufacturing, Inc.2003-10-08
MODEL 120 SERIES MATERNAL/FETAL MONITOR (K032252)Ge Medical Systems Information Technologies2003-08-21
BATTERY, RECHARGEABLE (K030261)Access Battery, Inc.2003-04-24
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A (K023931)Philips Medical Systems, Inc.2003-02-24
SONICAID ONE (K023618)Oxford Instruments Medical , Ltd.2003-01-22
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER (K021574)Card Guard Scientific Survival , Ltd.2002-08-12
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR (K021135)Ge Medical Systems Information Technologies2002-05-09
VERSALAB APM (K013281)Nicolet Biomedical2002-04-18
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (K014094)Hill-Rom Manufacturing, Inc.2002-01-11
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. (K012718)Ge Medical Systems Information Technologies2001-11-13
OB-1 FETAL MONITOR (K011304)Analogic Corp.2001-05-29
CG-900P FETAL/MATERNAL MONITOR (K010552)Card Guard Scientific Survival , Ltd.2001-05-11
SONICAID SYSTEM 8002 (K992607)Oxford Instruments Medical Systems2001-04-27
BABY DOPPLEX 3000 MK 2 (BD3000) (K010889)Huntleigh Healthcare, Inc.2001-04-25
BABY DOPPLEX 3002 (BD3002) (K010894)Huntleigh Healthcare, Inc.2001-04-25
SONICAID FM820, SONICAID FM830 (K002150)Oxford Instruments2001-03-09
FETAL ASSIST (K002548)Huntleigh Diagnostics , Ltd.2001-03-06
FETALGARD LITE (K002503)Analogic Corp.2000-11-09
BIOSYS FETAL MONITOR, MODEL IFM-500 (K994008)Biosys Co. , Ltd.2000-09-29
BABY DOPPLEX 4002-TWINS, MODEL BD4002 (K001882)Huntleigh Healthcare, Inc.2000-09-19
BABY DOPPLEX 4000 (BD4000) (K001677)Huntleigh Diagnostics , Ltd.2000-08-14
COROMETRICS MODEL 173 FETAL MONITOR (K993751)Ge Medical Systems Information Technologies2000-02-02
BABY DOPPLEX 4000, MODEL BD 4000 (K990569)Huntleigh Healthcare, Inc.2000-01-24
QUANTITATIVE SENTINEL SYSTEM (K993008)Marquette Medical Systems, Inc.1999-12-06
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