Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))— 510(k) K250625

Substantially Equivalent

Nanjing Yinuoji Medical Technology Co., Ltd.

FDA 510(k) clearance K250625 for Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)), Substantially Equivalent on 2025-08-27. Applicant: Nanjing Yinuoji Medical Technology Co., Ltd..

Clearance details

Applicant: Nanjing Yinuoji Medical Technology Co., Ltd.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2025-03-03
Decision date: 2025-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, 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.