Protable Phlegm Suction Unit (JMA D01)— 510(k) K250964

Substantially Equivalent

Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

FDA 510(k) clearance K250964 for Protable Phlegm Suction Unit (JMA D01), Substantially Equivalent on 2026-05-11. Applicant: Jiangsu Jumao X-Care Medical Equipment Co., Ltd..

Clearance details

Applicant: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2025-03-31
Decision date: 2026-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danyang, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.