510(k) K251615
K251615 is an FDA 510(k) premarket notification submitted by Aerogen, Ltd. for the device "Aerogen Pro-X1 Controller System". The FDA issued a decision of Substantially Equivalent on September 2, 2025. The device falls under product code SFP (Ventilator-Compatible Nebulizer), a Class II device regulated under 21 CFR 868.5630. Aerogen, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2025
- Date Received
- May 27, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator-Compatible Nebulizer
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type
The device is intended to deliver nebulized medications through a ventilator breathing circuit.