DeVilbiss 5 Liter Oxygen Concentrator (555)— 510(k) K253549
Substantially EquivalentDevilbiss Healthcare, LLC
FDA 510(k) clearance K253549 for DeVilbiss 5 Liter Oxygen Concentrator (555), Substantially Equivalent on 2026-03-26. Applicant: Devilbiss Healthcare, LLC. Device class: 2.
Summary
Devilbiss Healthcare's DeVilbiss 5 Liter Oxygen Concentrator (555) is filed under CAW, portable oxygen generators. The record doesn't describe it beyond its name and that code name.
Class II, 21 CFR 868.5440. It was a Traditional 510(k), and Anesthesiology is both the classification panel and the review panel.
Devilbiss Healthcare filed from Somerset, Pennsylvania. The decision came 132 calendar days after FDA received it (November 14, 2025 to March 26, 2026).
Clearance details
- Applicant
- Devilbiss Healthcare, LLC
- Product code
- Product code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerset, PA, US
Recent devices under product code CAW
view allMore clearances from Devilbiss Healthcare, LLC
view allAdverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.