Cleared Traditional

K251615 - Aerogen Pro-X1 Controller System

K251615 is an FDA 510(k) clearance for Aerogen Pro-X1 Controller System, manufactured by Aerogen, Ltd.. The device is a Class 2 Anesthesiology device with product code SFP cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K251615 · Aerogen, Ltd. · Anesthesiology device
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Sep 2025
Decision
98d
Days
Class 2
Risk

K251615 is an FDA 510(k) clearance for the Aerogen Pro-X1 Controller System. Classified as Ventilator-compatible Nebulizer (product code SFP), Class II - Special Controls.

Submitted by Aerogen, Ltd. (Galway, IE). The FDA issued a Cleared decision on September 2, 2025 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aerogen, Ltd. devices

FDA 510(k) Submission Details - K251615

510(k) Number K251615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SFP Device Classification - Class 2, Special Controls

Product Code SFP Ventilator-compatible Nebulizer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
Definition The Device Is Intended To Deliver Nebulized Medications Through A Ventilator Breathing Circuit.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.