510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251615Substantially Equivalent

Aerogen Pro-X1 Controller System

Aerogen Ltd., Galway, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251615 is the FDA 510(k) clearance record for Aerogen Pro-X1 Controller System, a class II device, cleared for Aerogen, Ltd. 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 10 510(k) clearances for Aerogen, Ltd., from to . As of , FDA records show no recalls naming K251615.

Clearance record

Decision date
Received
(98 days to decision)
Product code
SFP Ventilator-Compatible Nebulizer
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Aerogen, Ltd. Galway Business Park, Galway, IE
510(k) summary
Summary PDF
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