Data / Medical devices / United States / Airicu Inc.
Airicu Inc.: FDA-registered device maker in City of Industry, CA, United States, 1 510(k) clearance
Airicu Inc. is registered with the FDA (registration 3044320625) in City of Industry, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 12, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3044320625
- Address
- 220 N California Ave Ste A, City of Industry, CA, United States, 91744
- Owner or operator
- AIRICU INC. (10095528)
- Roles
- Complaint file establishment
- First device listed
- March 24, 2026
- Registered through
- 2026
- Brand names listed
- Adapter: ICU NA1, ICU NA2, ICU NAH1, ICU NAH2, Adult T-Piece, Air Flow Sensor, Medical Mesh Nebulizer, Medical Mesh Nebulizer AirICU Max+ ST, Medication Cup, Sensor Adapter, Sensor Adapter: ICU SAH22, ICU SA22M, ICU SAH22M and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Complaint file establishment | accessdata.fda.gov |
| Ventilator-Compatible Nebulizer | SFP | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 12, 2026 | K251584 | Medical Mesh Nebulizer (AirICU Max+) | SFP | Substantially Equivalent | AIRICU, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator-Compatible Nebulizer
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
Updated March 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.