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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K253647

510(k) cleared

Evita (V800); Evita (V600)

Draegerwerk AG & CO Kgaa · May 7, 2026 · K253647

FDA cleared the Evita (V800); Evita (V600) from Draegerwerk AG & CO Kgaa on May 7, 2026 under K253647, a traditional 510(k). The device falls under product code CBK, Ventilator, Continuous, Facility Use, regulated at 21 CFR 868.5895 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Nov 20, 2025. The decision came 168 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Draegerwerk AG & CO Kgaa in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253647?

K253647 is the FDA 510(k) for Evita (V800); Evita (V600), submitted by Draegerwerk AG & CO Kgaa. FDA's decision date was May 7, 2026, under product code CBK (Ventilator, Continuous, Facility Use).

Who makes the Evita (V800); Evita (V600)?

Draegerwerk AG & CO Kgaa, based in Luebeck, is the applicant of record for K253647.

How long did the K253647 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on May 7, 2026, 168 days later.

← All decisions in May 2026