# K100358: Central Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jan 6, 2011 after 328 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K091175: Grind NO More Version 2 and 3, Ranir, LLC (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K112159: CMS-1000FM Central Monitoring System (2011), 0 descendants of its own

## Indications for use
The Maternal Fetal Monitoring - Central Nurse System (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 * FHR * uterine activity (via tocodynamometry or IUP) * maternal heart rate * SpO2 * NIBP * respiratory rate * temperature * pulse rate

Source page: https://510kreport.com/device/K100358
Methodology: https://510kreport.com/methodology