# K120727: MFM-CMS Central Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jun 21, 2013 after 469 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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: 2 generations back to K011093 (2001). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062194: Hypervisor VI Central Monitoring System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K172966: CMS-2000 Central Monitoring System (2017), 0 descendants of its own
- K170514: Central Monitoring System (2017), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1150-2026: 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
MFM-CMS is a software application that is intended for use as a clinical data managing system (also referred to as a clinical information system - CIS).The MFM-CMS Central Monitoring System offers centralized physiological information management of adult, pediatric and neonatal patients which is automatically acquired from multiple bedside monitors. The MFM-CMS provides: collection, display and documentation of data from bedside monitors, viewing of patient physiologic data at remote locations and alarms when the results of the physiologic parameters exceed the user defined limit. It operates with off-the-shelf software and hardware. The system is intended for use in a hospital/clinical environment.

Source page: https://510kreport.com/device/K120727
Methodology: https://510kreport.com/methodology