Oxygen Concentrator-P2-O5E— 510(k) K251764

Substantially Equivalent

Qingdao Kingon Medical Science and Technology Co., Ltd.

FDA 510(k) clearance K251764 for Oxygen Concentrator-P2-O5E, Substantially Equivalent on 2025-12-22. Applicant: Qingdao Kingon Medical Science and Technology Co., Ltd..

Clearance details

Applicant: Qingdao Kingon Medical Science and Technology Co., Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2025-06-09
Decision date: 2025-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qingdao, CN

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.