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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 / March 2026 / K251584

510(k) cleared

Medical Mesh Nebulizer (AirICU Max+)

AIRICU, Inc. · Mar 12, 2026 · K251584

FDA cleared the Medical Mesh Nebulizer (AirICU Max+) from AIRICU, Inc. on Mar 12, 2026 under K251584, a traditional 510(k). The device falls under product code SFP, Ventilator-Compatible Nebulizer, regulated at 21 CFR 868.5630 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on May 23, 2025. The decision came 293 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 AIRICU, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251584?

K251584 is the FDA 510(k) for Medical Mesh Nebulizer (AirICU Max+), submitted by AIRICU, Inc.. FDA's decision date was Mar 12, 2026, under product code SFP (Ventilator-Compatible Nebulizer).

Who makes the Medical Mesh Nebulizer (AirICU Max+)?

AIRICU, Inc., based in City Of Industry, CA, is the applicant of record for K251584.

How long did the K251584 review take?

FDA received the submission on May 23, 2025 and issued its decision on Mar 12, 2026, 293 days later.

← All decisions in March 2026