Cleared Traditional

Aerogen Pro-X1 Controller System

K251615 · Aerogen, Ltd. · Anesthesiology

Sep 2025

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K251615 is an FDA 510(k) clearance for the Aerogen Pro-X1 Controller System, a Ventilator-compatible Nebulizer (Class II — Special Controls, product code SFP), submitted by Aerogen, Ltd. (Galway, IE). The FDA issued a Cleared decision on September 2, 2025, 98 days after receiving the submission on May 27, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K251615 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2025
Decision Date	September 02, 2025
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	SFP — Ventilator-compatible Nebulizer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5630
Definition	The Device Is Intended To Deliver Nebulized Medications Through A Ventilator Breathing Circuit.