Medical Device Manufacturer · US , City Of Industry , CA

AIRICU, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2026

Total

Cleared

Denied

AIRICU, Inc. specializes in aerosol drug delivery systems for acute care settings. The company develops portable medical nebulizers designed for patients on and off mechanical ventilation. With a manufacturing facility in City of Industry, California, AIRICU focuses on synchronized drug delivery precision in intensive care environments.

The company has received 1 FDA 510(k) clearance from 1 total submission. AIRICU's regulatory activity centers on Anesthesiology devices, with its most recent clearance in 2026. The AirICU Max+ medical mesh nebulizer represents the company's core cleared product for critical care aerosol therapy.

AIRICU operates as an active medical device manufacturer with recent FDA clearance demonstrating ongoing product development. The company is part of the feellife group, a healthcare organization focused on respiratory tract treatments. Notable recognition includes MedTech Top 20 Innovative Healthcare Companies designation and multiple international awards for nebulization solutions.

Explore the company's cleared device names, product codes, and clearance dates in the database above.

FDA 510(k) Regulatory Record - AIRICU, Inc.

1 devices

1-1 of 1

Cleared Mar 12, 2026

Medical Mesh Nebulizer (AirICU Max+)

K251584 · SFP

Anesthesiology · 293d

AIRICU, Inc. - FDA 510(k) Cleared Devices

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