# K143695: Central Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Mar 30, 2015 after 96 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K833395 (1984). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103172: Civ-OB (Plus), Civnet Communication, Ltd. (2011) Summary page 4.
- K081203: OB Tracevue Obstetrical Information Management System with Release F.00, Philips Medizin Systeme Boeblingen GmbH (2008) Summary page 4.

## Most influential descendants
- K171178: Central Monitoring System (2017), 0 descendants of its own

## Indications for use
The Maternal Fetal Monitoring – Central Nurse System (hereinafter called "MFM-CNS") is a clinical data managing software application and is indicated for antepartum and intrapartum monitoring of pregnant women in a healthcare setting. The MFM-CNS is intended to manage perinatal monitoring data acquired from bedside monitors or manual input for viewing at the central nursing station. The system also produces an electronic medical record. The MFM-CNS has display fields for the following obstetric data: - patient demographics - provider notes - fetal heart rate (FHR) - uterine activity (via tocodynamometry or IUP) - fetal movement - maternal heart rate - SpO2 - non-invasive blood pressure (NIBP) - respiratory rate - temperature - pulse

Source page: https://510kreport.com/device/K143695
Methodology: https://510kreport.com/methodology