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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 / April 2026 / K251583

510(k) cleared

Ambu® Virobac II® Exhalation Filter

Ambu A/S · Apr 30, 2026 · K251583

FDA cleared the Ambu® Virobac II® Exhalation Filter from Ambu A/S on Apr 30, 2026 under K251583, a traditional 510(k). The device falls under product code CAH, Filter, Bacterial, Breathing-Circuit, regulated at 21 CFR 868.5260 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on May 23, 2025. The decision came 342 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ambu A/S has one other decision in the tracker over the last 12 months: K260578 (Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)).

Questions & Answers

What did FDA clear under K251583?

K251583 is the FDA 510(k) for Ambu® Virobac II® Exhalation Filter, submitted by Ambu A/S. FDA's decision date was Apr 30, 2026, under product code CAH (Filter, Bacterial, Breathing-Circuit).

Who makes the Ambu® Virobac II® Exhalation Filter?

Ambu A/S, based in Ballerup, is the applicant of record for K251583.

How long did the K251583 review take?

FDA received the submission on May 23, 2025 and issued its decision on Apr 30, 2026, 342 days later.

← All decisions in April 2026