FDA 510(k)

Aerogen Pro-X1 Controller System

K-Number: K251615 · 2025-09-02

Decision Date2025-09-02

Product CodeSFP

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Aerogen Pro-X1 Controller System is the device name listed in this FDA 510(k) record. The listed applicant is Aerogen, Ltd.. It received FDA 510(k) clearance on 2025-09-02 under 510(k) number K251615. The device is classified under product code SFP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aerogen Pro-X1 Controller System?

Aerogen Pro-X1 Controller System is a medical device that received FDA 510(k) clearance on 2025-09-02. The listed applicant is Aerogen, Ltd.. The 510(k) number is K251615.

When did Aerogen Pro-X1 Controller System receive FDA 510(k) clearance?

Aerogen Pro-X1 Controller System received FDA 510(k) clearance on 2025-09-02, under 510(k) number K251615.

Who is the listed applicant for Aerogen Pro-X1 Controller System?

The FDA 510(k) record lists Aerogen, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aerogen Pro-X1 Controller System?

The FDA product code for Aerogen Pro-X1 Controller System is SFP.

Other records listing Aerogen, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232507Aerogen®Solo Nebulizer System

Related Devices (Code: SFP)

K251584Medical Mesh Nebulizer (AirICU Max+)AIRICU, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.