Panels › Anesthesiology › Product code SFP · Class 2
Ventilator-Compatible Nebulizer
Regulation 868.5630
1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SFP
| Company | 510(k)s | Recalls |
|---|---|---|
| Aerogen, Ltd. | 1 | 0 |
| AIRICU, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 12, 2026 | K251584 | Medical Mesh Nebulizer (AirICU Max+) AIRICU, Inc. | SFP |
| Sep 2, 2025 | K251615 | Aerogen Pro-X1 Controller System Aerogen, Ltd., IE | SFP |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.