510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K251584Substantially Equivalent

Medical Mesh Nebulizer (AirICU Max+)

Airicu Inc., City Of Industry CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K251584 is the FDA 510(k) clearance record for Medical Mesh Nebulizer (AirICU Max+), a class II device, cleared for AIRICU, Inc. on under FDA product code SFP (Ventilator-Compatible Nebulizer). FDA's definition for product code SFP reads: "The device is intended to deliver nebulized medications through a ventilator breathing circuit". FDA records list one 510(k) clearance for AIRICU, Inc. As of , FDA records show no recalls naming K251584.

Clearance record

Decision date
Received
(293 days to decision)
Product code
SFP Ventilator-Compatible Nebulizer
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
AIRICU, Inc. 220 N California Suite A, City Of Industry CA
510(k) summary
Statement
Third party review
No

Clearances, product code SFP

Trailing 12 months
1 clearance under product code SFP in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SFP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260