MAQUET Critical Care Receives 510(k) Clearance

MAQUET Critical Care AB today announced it has received 510(k) clearance from the U.S. Food and Drug Administration for its MAQUET FLOW-i anesthesia system, including the C20, C30 and C40 models.

FLOW-i is a high performance system designed to meet ventilatory challenges within anesthesia, as well as to provide inhalation anesthesia in a broad range of patients, from neonatal to adult.
The system is intended for use in administrating anesthesia while controlling the entire ventilation in patients with no ability or limited ability to breathe. MAQUET Critical Care’s FLOW-i anesthesia delivery system combines advanced ICU SERVO ventilator performance with state-of-the-art anesthesia delivery.

”The 510(k) clearance allows us to further serve the US hospital market with a differentiated anesthesia system due to its high performance ventilation capabilities,” said Jens Viebke, President at MAQUET Critical Care AB. “The OR is a very demanding environment and anesthesia systems need be able to adapt to the situation at hand. MAQUET Critical Care’s FLOW-i provides a supportive and efficient workflow convenience through advanced anesthesia delivery, powerful ventilation based on the SERVO heritage and ease of use.”

The SERVO is known for exceptionally high clinical and technical performance, ensuring safe, reliable and high quality ventilation. FLOW-i, based on the SERVO ventilation platform, gives clinicians advanced ventilation performance when it is needed the most, while allowing patients to benefit from optimized perioperative
ventilatory support in the OR. FLOW-i can be used across the widest range of patient groups, including those with acute respiratory demands and pediatric patients.

FLOW-i is available in three models:

C20 with extra storage, C30 that can be adjusted by height and the C40 which is a ceiling pendant. All models feature flexible, tiltable screen positioning allowing for maximized screen visibility. Due to smart and ergonomic design, all models are safe, easy to maneuver and position, as well as easy to clean.

Powerful benefits:
- FLOW-i enables enhanced mechanical ventilator capabilities and anesthesia delivery from the same unit - setting new standards in anesthesia
- FLOW-i enables power to perform on demand
- FLOW-i enables an optimized workflow that makes it easy to work with
- FLOW-i enables flexible configurations according to individual needs