# K232694: Central Monitoring System (MFM-CMS)

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 5, 2024 after 153 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: 31 generations back to K941811 (1994). 193 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220058: BeneVision Central Monitoring System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2022) Summary page 5.

## Most influential descendants
- K250349: Vista CMS (2026), 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 central monitoring system (hereinafter referred to as MFM-CMS) supports centralized management of patients' clinical data provided by EDAN medical devices. Clinicians can obtain patient clinical data via MFM-CMS. The indications for use of the MFM-CMS central monitoring system include: * Viewing patient real-time clinical data and alarms. * Storing and reviewing patient clinical data and alarms. * Printing real-time and history patient data. * Configuring local settings as well as synchronizing settings to a remote device through network. * Accessing patient clinical data between several departments. MFM-CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals. MFM-CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data.

Source page: https://510kreport.com/device/K232694
Methodology: https://510kreport.com/methodology