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

Name: FDA 510(k) clearance K250964
Creator: U.S. Food and Drug Administration
Published: 2026-05-11

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.. Device class: 2.

Clearance details

Applicant: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
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 ↗

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K243418 — Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing2024-12-02
K233428 — Easycess Aspiration Pump2023-11-03
K222552 — 120V Neptune S Rover (0711-001-000) +3 more2022-12-09

More clearances from Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

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K253632 — Manual Wheelchair (W50)2026-01-29
K252825 — Manual Wheelchair (W45)2025-12-05
K252828 — Manual Wheelchair (W47)2025-12-05
K251130 — Portable Oxygen Concentrator (JM-P50A)2025-08-21
K232783 — Power wheelchair (Model: JMPW-01W)2024-01-19

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.