# K250349: Vista CMS

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Draeger Medical Instrument Co., Ltd.
- Decided: Apr 24, 2026 after 441 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 32 generations back to K941811 (1994). 194 ancestors in all.
No later device cites it as a predicate yet.
0 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232694: Central Monitoring System (MFM-CMS), Edan Instruments, Inc. (2024) Summary page 5.

## Indications for use
Vista central monitoring software (hereinafter referred to as Vista CMS) supports centralized management of patients' clinical data provided by Vista Series patient monitors. Clinicians can obtain patient clinical data from networked devices via Vista CMS. The functionalities of Vista CMS 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. Vista CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals. Vista 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/K250349
Methodology: https://510kreport.com/methodology