K251615 is an FDA 510(k) clearance for the Aerogen Pro-X1 Controller System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.5630. The Device Is Intended To Deliver Nebulized Medications Through A Ventilator Breathing Circuit..
| 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 |
| 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. |