Protable Phlegm Suction Unit (JMA D01)— 510(k) K250964
Substantially EquivalentJiangsu 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.. Device class: 2.
Summary
Jiangsu Jumao X-Care Medical Equipment's device is named "Protable Phlegm Suction Unit (JMA D01)" in the record, spelling included. It's filed under JCX, AC-powered portable ward-use suction apparatus.
Class II, 21 CFR 878.4780. General and Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
Jumao filed from Danyang, China. The decision came 406 calendar days after receipt (March 31, 2025 to May 11, 2026).
Clearance details
- Applicant
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
- Product code
- Product code JCX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danyang, CN
Recent devices under product code JCX
view allMore clearances from Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
view allAdverse events under product code JCX
product code JCX- Death
- 11
- Malfunction
- 838
- Other
- 1
- Total
- 850
Source: openFDA MAUDE database, through . 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.