Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HGM — Predicate Candidate Screening
214 FDA 510(k) clearances under this product code; the 50 most recent screened below.
93 daysmedian FDA review time
328 days90th percentile
214clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253021 | ANNE Maternal | Sibel Health, Inc. | 2026-02-26 | 160 | 0 |
| K250777 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | 2025-09-19 | 189 | 0 |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025-08-27 | 425 | 0 |
| K241368 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | 2025-02-03 | 265 | 0 |
| K241009 | PeriCALM Patterns 3.0 | Perigen, Inc. | 2025-01-10 | 273 | 0 |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fet | Philips Medizin Systeme Boeblingen GmbH | 2024-07-02 | 258 | 0 |
| K231964 | Novii+ Wireless Patch System | Datex Ohmeda | 2023-12-08 | 158 | 0 |
| K222327 | Bloomlife MFM-Pro | Bloom Technologies NV | 2023-02-13 | 195 | 0 |
| K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | 2022-06-23 | 101 | 0 |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited | 2020-06-24 | 72 | 0 |
| K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | 2018-09-10 | 258 | 0 |
| K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Expr | Edan Instruments, Inc. | 2018-08-30 | 336 | 2 |
| K173715 | AlertWatch:OB | Alertwatch, Inc. | 2018-04-23 | 140 | 0 |
| K171178 | Central Monitoring System | Edan Instruments, Inc. | 2017-09-06 | 138 | 1 |
| K171865 | F1 Mothership Wireless Transducers for Fetal Ultrasonic and | Farus, LLC | 2017-08-24 | 63 | 0 |
| K161902 | Meridian M110 Fetal Monitoring System | Mindchild Medical | 2017-01-12 | 185 | 0 |
| K153580 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | 2016-09-07 | 267 | 0 |
| K150398 | EUM 100Pro | Ob Tools, Ltd. | 2015-08-06 | 169 | 0 |
| K142799 | Model BT-220L and BT-220C | Bistos Co., Ltd. | 2015-07-09 | 283 | 0 |
| K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Expr | Edan Instruments, Inc. | 2015-07-01 | 89 | 1 |
| K142883 | MindChild Meridian M100 Fetal Heart Rate Monitor | Mindchild Medical | 2015-04-17 | 197 | 0 |
| K143695 | CENTRAL MONITORING SYSTEM | Edan Instruments, Inc. | 2015-03-30 | 96 | 0 |
| K140535 | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AN | Philips Medizin Systeme Boblingen GmbH | 2014-11-25 | 266 | 3 |
| K141194 | FM-3000 FETAL MONITOR | Advanced Instrumentations, Inc. | 2014-11-19 | 195 | 0 |
| K131941 | FETAL MONITORS | Guangdong Biolight Meditech Co., Ltd. | 2014-05-15 | 322 | 0 |
| K132650 | SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM | Huntleigh Healthcare Limited | 2014-02-07 | 165 | 0 |
| K132918 | SENSE-4BABY SYSTEM | Sense4baby , Inc. | 2013-11-22 | 66 | 0 |
| K123335 | SUNRAY FETAL MONITOR | Sunray Medical Apparatus Co., Ltd. | 2013-03-21 | 146 | 0 |
| K121758 | CERNER FETALINK+(VERSION1.0) | Cerner Corp. | 2012-10-09 | 116 | 0 |
| K120018 | MINDCHILD MERIDIAN FETAL HEART RATE MONITOR | Mindchild Medical | 2012-09-19 | 260 | 0 |
| K121267 | BT-200V VASCULAR DOPPLER | Bistos Co., Ltd. | 2012-08-02 | 98 | 0 |
| K121208 | OBIX PERINATAL DATA SYSTEM 7.0 | Clinical Computer Systems, Inc. | 2012-06-14 | 55 | 0 |
| K112317 | FM-9000 PLUS FETAL AND MATERNAL MONITOR | Advanced Instrumentations, Inc. | 2011-12-21 | 132 | 0 |
| K110612 | FM20 | Mediana Co., Ltd. | 2011-11-08 | 250 | 0 |
| K111614 | CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE | Ge Healthcare Integrated IT Solutions | 2011-09-26 | 110 | 1 |
| K112187 | FM-1000 PLUS FETAL MONITOR | Advanced Instrumentations, Inc. | 2011-09-21 | 54 | 0 |
| K112159 | CMS-1000FM CENTRAL MONITORING SYSTEM | Advanced Instrumentations, Inc. | 2011-09-21 | 56 | 0 |
| K111083 | PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-08-17 | 120 | 1 |
| K110556 | MINI TELEMETRY SYSTEM | Wipro GE Healthcare Private, Ltd. | 2011-07-19 | 141 | 0 |
| K103545 | BT-350 | Bistos Co., Ltd. | 2011-05-13 | 162 | 0 |
| K102263 | HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSO | Mckesson Information Solutions, LLC | 2011-05-05 | 268 | 0 |
| K102958 | PHILIPS AVALON FETAL MONITOR | Philips Medizin Systeme Boblingen GmbH | 2011-03-18 | 165 | 0 |
| K103172 | CIV-OB (PLUS) | Civnet Communication, Ltd. | 2011-03-11 | 134 | 0 |
| K102140 | FETAL MONITORS, MODELS F2 AND F3 | Edan Instruments, Inc. | 2011-01-13 | 168 | 1 |
| K100358 | CENTRAL MONITORING SYSTEM | Edan Instruments, Inc. | 2011-01-06 | 328 | 0 |
| K100797 | FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS | Edan Instruments, Inc. | 2010-11-10 | 233 | 0 |
| K100420 | PHILIPS OBTRACEVUE MODEL SW REV. G.00 | Philips Medizin Systeme Boeblingen GmbH | 2010-07-26 | 160 | 0 |
| K100885 | FETAL MONITOR MODEL: BT-200T | Bistos Co., Ltd. | 2010-06-07 | 69 | 0 |
| K092028 | PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 | Philips Medizin Systeme Boeblingen GmbH | 2010-02-17 | 226 | 0 |
| K091251 | CERNER FETALINK (VERSION 1.0) | Cerner Corp. | 2009-08-25 | 118 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda