Draegerwerk AG & CO Kgaa · Class II · Cleared May 7, 2026
| K-number | K253647 |
| Device name | Evita (V800); Evita (V600) |
| Applicant | Draegerwerk AG & CO Kgaa |
| Product code | CBK |
| Device class | Class II |
| Decision date | May 7, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 868.5895 |
The Evita V800 and Evita V600 are intensive care ventilators intended for ventilation of adults, pediatric patients, and neonates weighing at least 0.4 kg. They provide mandatory and spontaneous ventilation modes with monitoring capabilities and are designed for stationary use in hospitals and medical rooms or for intrahospital transport by qualified, trained medical personnel.
Key differences from the predicate include: decelerating-flow setting in volume control modes (comparable to SERVO-U), selectable minute-volume alarm source with auto-set feature for alarm limits, automated driving-pressure procedure, PEEP/FiO2 display view, GUI harmonization with updated layout, SmartCare/PS migrated from Java to MATLAB/Simulink, extended battery maintenance interval (6 vs 4 years for LFP), updated air-inlet labeling, and server-triggered software updates.
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-10, ISO 80601-2-12, ISO 80601-2-55, ISO 80601-2-90, ISO 14971, IEC 62304, IEC 62366-1, ISO 10993-1, ISO 18562 series, IEC 62133 series, ISO 17664 series, and TR 60601-4-2.
The Evita V800/V600 is substantially equivalent to the predicate device (K222024) because it maintains the same intended use, patient populations, ventilation modes, and core therapeutic functions. All technological differences represent minor enhancements without introducing new use-related risks; extensive non-clinical testing including software validation, biocompatibility, electrical safety, and usability validation per IEC 62366-1 confirms equivalence. No clinical data were required.
View the full FDA submission: accessdata.fda.gov