# K171178: Central Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Sep 6, 2017 after 138 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K833395 (1984). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143695: Central Monitoring System, Edan Instruments, Inc. (2015) Summary page 5.

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1151-2026: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

## 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. 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. MFM-CNS has display fields for the following obstetric data: patient demographics provider notes fetal heart rate (FHR) uterine activity fetal movement maternal heart rate SpO2 non-invasive blood pressure (NIBP) respiratory rate temperature pulse rate MFM-CNS Lite (hereinafter called "Lite") is a clinical data managing software application and is indicated for antepartum monitoring of pregnant women in a healthcare setting. Lite is intended to manage antepartum-monitoring data acquired from bedside monitors and produce electronic medical records. Lite has display fields for the following obstetric data: patient demographics provider notes fetal heart rate (FHR) uterine activity fetal movement

Source page: https://510kreport.com/device/K171178
Methodology: https://510kreport.com/methodology