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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 / K260892

510(k) cleared

Suction Pump (SU-90)

Shenzhen HugeMed Medical Technical Development Co., Ltd. · May 14, 2026 · K260892

FDA cleared the Suction Pump (SU-90) from Shenzhen HugeMed Medical Technical Development Co., Ltd. on May 14, 2026 under K260892, a traditional 510(k). The device falls under product code BTA, Pump, Portable, Aspiration (Manual Or 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 18, 2026. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shenzhen HugeMed Medical Technical Development Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260892?

K260892 is the FDA 510(k) for Suction Pump (SU-90), submitted by Shenzhen HugeMed Medical Technical Development Co., Ltd.. FDA's decision date was May 14, 2026, under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).

Who makes the Suction Pump (SU-90)?

Shenzhen HugeMed Medical Technical Development Co., Ltd., based in Shenzhen, is the applicant of record for K260892.

How long did the K260892 review take?

FDA received the submission on Mar 18, 2026 and issued its decision on May 14, 2026, 57 days later.

← All decisions in May 2026