V series portable oxygen concentrator (V5, V5C, V6, V6C)— 510(k) K252268

Substantially Equivalent

Shenzhen Harveymed Technology Co., Ltd.

FDA 510(k) clearance K252268 for V series portable oxygen concentrator (V5, V5C, V6, V6C), Substantially Equivalent on 2025-12-16. Applicant: Shenzhen Harveymed Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Harveymed Technology Co., Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2025-07-21
Decision date: 2025-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.