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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 / K254078

510(k) cleared

HVT 2.0

Vapotherm, Inc. · Apr 13, 2026 · K254078

FDA cleared the HVT 2.0 from Vapotherm, Inc. on Apr 13, 2026 under K254078, a traditional 510(k). The device falls under product code BTT, Humidifier, Respiratory Gas, (Direct Patient Interface), regulated at 21 CFR 868.5450 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Dec 18, 2025. The decision came 116 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 Vapotherm, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254078?

K254078 is the FDA 510(k) for HVT 2.0, submitted by Vapotherm, Inc.. FDA's decision date was Apr 13, 2026, under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)).

Who makes the HVT 2.0?

Vapotherm, Inc., based in Exeter, NH, is the applicant of record for K254078.

How long did the K254078 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Apr 13, 2026, 116 days later.

← All decisions in April 2026