Vista CMS— 510(k) K250349
Substantially EquivalentShanghai Draeger Medical Instrument Co., Ltd.
FDA 510(k) clearance K250349 for Vista CMS, Substantially Equivalent on 2026-04-24. Applicant: Shanghai Draeger Medical Instrument Co., Ltd.. Device class: 2.
Summary
Vista CMS comes from Shanghai Draeger Medical Instrument and is filed under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 870.1025. It came in as a Traditional 510(k), and Cardiovascular is both the classification panel and the review panel.
Shanghai Draeger Medical Instrument filed from Shanghai, China. Review took 441 calendar days (February 7, 2025 to April 24, 2026).
Clearance details
- 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.