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)— 510(k) K252250

Substantially Equivalent

Shanghai Draeger Medical Instrument Co., Ltd.

FDA 510(k) clearance K252250 for 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), Substantially Equivalent on 2026-04-10. Applicant: Shanghai Draeger Medical Instrument Co., Ltd..

Summary

The Vista 300 family is a multi-parameter patient monitor, product code MHX — the broad category for bedside physiologic monitors displaying ECG, SpO2, NIBP, temperature, and related vitals. The filing covers both invasive and non-invasive variants across two model tiers (Vista 300 and Vista 300 S), with US-specific SKU numbering.

Cardiovascular panel review (MHX is assigned there despite the broader hospital application), Traditional 510(k). The multi-SKU, multi-variant filing is typical of patient-monitor 510(k)s where a manufacturer clears a platform refresh across all configurations at once.

Shanghai Draeger is the China subsidiary of the German Drägerwerk group. Monitor clearances for the US market are often filed through regional subsidiaries like this when manufacturing is regional.

Clearance details

Applicant: Shanghai Draeger Medical Instrument Co., Ltd.
Product code: Code MHX
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 ↗

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.