WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K250964

510(k) cleared

Protable Phlegm Suction Unit (JMA D01)

Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · May 11, 2026 · K250964

FDA cleared the Protable Phlegm Suction Unit (JMA D01) from Jiangsu Jumao X-Care Medical Equipment Co., Ltd. on May 11, 2026 under K250964, a traditional 510(k). The device falls under product code JCX, Apparatus, Suction, Ward Use, Portable, Ac-Powered, regulated at 21 CFR 878.4780 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 31, 2025. The decision came 406 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Jiangsu Jumao X-Care Medical Equipment Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K253632 (Manual Wheelchair (W50)), K252825 (Manual Wheelchair (W45)), K252828 (Manual Wheelchair (W47)).

Questions & Answers

What did FDA clear under K250964?

K250964 is the FDA 510(k) for Protable Phlegm Suction Unit (JMA D01), submitted by Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. FDA's decision date was May 11, 2026, under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered).

Who makes the Protable Phlegm Suction Unit (JMA D01)?

Jiangsu Jumao X-Care Medical Equipment Co., Ltd., based in Danyang, is the applicant of record for K250964.

How long did the K250964 review take?

FDA received the submission on Mar 31, 2025 and issued its decision on May 11, 2026, 406 days later.

← All decisions in May 2026

Sources