O2 Concepts Oxlife Independence Model 301-0001— 510(k) K182454

Substantially Equivalent

O2 Concepts, LLC

FDA 510(k) clearance K182454 for O2 Concepts Oxlife Independence Model 301-0001, Substantially Equivalent on 2018-12-20. Applicant: O2 Concepts, LLC.

Clearance details

Applicant: O2 Concepts, LLC
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2018-09-07
Decision date: 2018-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middlebury, CT, 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.