Shanghai Draeger Medical Instrument Co., Ltd. · Class II · Cleared Apr 10, 2026
| K-number | K252250 |
| Device name | 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) |
| Applicant | Shanghai Draeger Medical Instrument Co., Ltd. |
| Product code | MHX |
| Device class | Class II |
| Decision date | Apr 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1025 |
The Vista 300 and Vista 300 S are bedside multiparameter physiological patient monitors intended for continuous monitoring of vital signs in adults, pediatrics, and neonates in hospital settings. They display ECG, blood pressure, oxygen saturation, temperature, respiration, carbon dioxide, cardiac output, and other parameters with integrated alarm functions, and support arrhythmia detection and ST-segment analysis for adult patients.
The Vista 300 features a 15.6-inch touchscreen display while Vista 300 S has a 13.3-inch display. Both support multiple monitoring modules (SpO2, BIS, NMT, CO2) that receive pre-processed data from FDA-cleared external modules rather than performing independent signal acquisition. They offer expanded Wi-Fi capabilities (2.4 GHz and 5 GHz bands) and modified interfaces compared to the predicate iX10/iX12/iX15 devices, with different power input specifications (≤2.0 A vs 1.6–0.8 A).
IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-1-8:2006, IEC 60601-2-25:2011, IEC 80601-2-26:2019, IEC 60601-2-27:2011, IEC 80601-2-30:2018, IEC 60601-2-34:2024, IEC 80601-2-49:2018, ISO 80601-2-55:2018, ISO 80601-2-56:2017, ISO 80601-2-61:2017, IEEE ANSI C63.27:2021, ANSI/AAMI EC57:2012, IEC 62304:2006, ISO 14971:2019, and ISO 15223-1:2021.
The Vista 300/300 S is substantially equivalent to predicate device K232962 (iX10/iX12/iX15) because both are multiparameter physiological monitors with identical intended use, regulatory classification, and core monitoring functions. All technological differences (display size, Wi-Fi bands, interface changes, external module integration) have been validated through comprehensive verification and testing to confirm they do not affect device accuracy, reliability, or safety; the device does not modify hardware or signal processing logic for reported parameters.
View the full FDA submission: accessdata.fda.gov