HGM · System, Monitoring, Perinatal
Obstetrics/Gynecology · 21 CFR 884.2740 · Class 2
Overview
| Product Code | HGM |
|---|---|
| Device Name | System, Monitoring, Perinatal |
| Regulation | 21 CFR 884.2740 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 214)
Showing 20 most recent of 214 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253021 | ANNE Maternal | Sibel Health, Inc. | Feb 26, 2026 | SESE |
| K250777 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | Sep 19, 2025 | SESE |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | Aug 27, 2025 | SESE |
| K241368 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | Feb 3, 2025 | SESE |
| K241009 | PeriCALM Patterns 3.0 | Perigen, Inc. | Jan 10, 2025 | SESE |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | Philips Medizin Systeme Boeblingen GmbH | Jul 2, 2024 | SESE |
| K231964 | Novii+ Wireless Patch System | Datex Ohmeda | Dec 8, 2023 | SESE |
| K222327 | Bloomlife MFM-Pro | Bloom Technologies NV | Feb 13, 2023 | SESE |
| K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | Jun 23, 2022 | SESE |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited | Jun 24, 2020 | SESE |
| K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | Sep 10, 2018 | SESE |
| K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 | Edan Instruments, Inc. | Aug 30, 2018 | SESE |
| K173715 | AlertWatch:OB | Alertwatch, Inc. | Apr 23, 2018 | SESE |
| K171178 | Central Monitoring System | Edan Instruments, Inc. | Sep 6, 2017 | SESE |
| K171865 | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring | Farus, LLC | Aug 24, 2017 | SESE |
| K161902 | Meridian M110 Fetal Monitoring System | Mindchild Medical | Jan 12, 2017 | SESE |
| K153580 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | Sep 7, 2016 | SESE |
| K150398 | EUM 100Pro | Ob Tools, Ltd. | Aug 6, 2015 | SESE |
| K142799 | Model BT-220L and BT-220C | Bistos Co., Ltd. | Jul 9, 2015 | SESE |
| K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | Edan Instruments, Inc. | Jul 1, 2015 | SESE |
Top Applicants
- Ge Medical Systems Information Technologies — 28 clearances
- Edan Instruments, Inc. — 12 clearances
- Hewlett-Packard Co. — 11 clearances
- Advantage Medical Systems, Inc. — 9 clearances
- Philips Medizin Systeme Boeblingen GmbH — 7 clearances
