K250805 is an FDA 510(k) clearance for the DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW). This device is classified as a Generator, Oxygen, Portable (Class II - Special Controls, product code CAW).
Submitted by Devilbiss Healthcare, LLC (Somerset, US). The FDA issued a Cleared decision on December 9, 2025, 267 days after receiving the submission on March 17, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5440.
| 510(k) Number | K250805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2025 |
| Decision Date | December 09, 2025 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAW - Generator, Oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5440 |