Vista 300/Vista 300 S +5 more— 510(k) K252250

Name: FDA 510(k) clearance K252250
Creator: U.S. Food and Drug Administration
Published: 2026-04-10

Substantially Equivalent

Shanghai Draeger Medical Instrument Co., Ltd.

FDA 510(k) clearance K252250 for Vista 300/Vista 300 S +5 more, Substantially Equivalent on 2026-04-10. Applicant: Shanghai Draeger Medical Instrument Co., Ltd.. Device class: 2.

Summary

This filing covers the Vista 300 and Vista 300 S patient monitors in five US configurations, split between non-invasive and invasive models. Product code MHX is for physiological patient monitors with arrhythmia detection or alarms: the bedside monitors that show ECG, SpO2, blood pressure, and related vitals.

Class II, 21 CFR 870.1025. The Cardiovascular panel reviewed it as a Traditional 510(k).

The applicant is Shanghai Draeger Medical Instrument, the Chinese arm of Germany's Drägerwerk, filing from Shanghai. Review took 267 days (July 17, 2025 to April 10, 2026). Clearing every configuration of a monitor platform in one submission is common practice.

Clearance details

Device name as filed: 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: Code MHX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2025-07-17
Decision date: 2026-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P2026-07-24

More clearances from Shanghai Draeger Medical Instrument Co., Ltd.

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.