Vista 300/Vista 300 S +5 more— 510(k) K252250
Substantially EquivalentShanghai 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.
Class II, 21 CFR 870.1025. The Cardiovascular panel reviewed it as a Traditional 510(k).
The applicant is Shanghai Draeger Medical Instrument, filing from Shanghai, China. Review took 267 days (July 17, 2025 to April 10, 2026).
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
- Product code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code MHX
view allMore clearances from Shanghai Draeger Medical Instrument Co., Ltd.
view allAdverse 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, through . 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.