DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES— 510(k) K081468

Substantially Equivalent

Sunrise Medical

FDA 510(k) clearance K081468 for DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES, Substantially Equivalent on 2008-08-25. Applicant: Sunrise Medical.

Clearance details

Applicant: Sunrise Medical
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2008-05-27
Decision date: 2008-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, PA, US

Download summary PDF View on FDA.gov ↗

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.