K250805

Substantially Equivalent

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)

Applicant: Devilbiss Healthcare, LLC
Product code: CAW
Advisory panel: Anesthesiology
Date received: 2025-03-17
Decision date: 2025-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, PA, US

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.