# K252250: Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Draeger Medical Instrument Co., Ltd.
- Decided: Apr 10, 2026 after 267 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: 35 generations back to K941811 (1994). 231 ancestors in all.
No later device cites it as a predicate yet.
1 of 232 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232962: Patient Monitor (iX10, iX12, iX15), Edan Instruments, Inc. (2024) Summary page 6.

## Indications for use
Vista 300: The monitors are intended to be used for monitoring, storing, recording and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic Gas (AG), bispectral index (BIS), neuromuscular transmission (NMT). The monitors are not intended for MRI environments. Vista 300 S: The monitors are intended to be used for monitoring, storing, recording and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.) (for adults only), anesthetic Gas (AG). The monitors are not intended for MRI environments. For Vista 300/Vista 300 S: The arrhythmia detection and ST Segment analysis are intended for adult patients. The NIBP monitoring supports iCUFS algorithm. The iCUFS algorithm is intended for adult, pediatric and neonatal patients. It is also intended for use with pregnant women, including pre-eclamptic patients. NIBP MAP is not applicable to pregnant women.

Source page: https://510kreport.com/device/K252250
Methodology: https://510kreport.com/methodology