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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 / December 2025 / K252494

510(k) cleared

Electrically powered wheelchair (KZ301B)

Nanjing Kangni Smart Technology Co., Ltd. · Dec 5, 2025 · K252494

FDA cleared the Electrically powered wheelchair (KZ301B) from Nanjing Kangni Smart Technology Co., Ltd. on Dec 5, 2025 under K252494, a traditional 510(k). The device falls under product code ITI, Wheelchair, Powered, regulated at 21 CFR 890.3860 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Aug 8, 2025. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nanjing Kangni Smart Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252502 (Folding Mobility Scooter (KD101)).

Questions & Answers

What did FDA clear under K252494?

K252494 is the FDA 510(k) for Electrically powered wheelchair (KZ301B), submitted by Nanjing Kangni Smart Technology Co., Ltd.. FDA's decision date was Dec 5, 2025, under product code ITI (Wheelchair, Powered).

Who makes the Electrically powered wheelchair (KZ301B)?

Nanjing Kangni Smart Technology Co., Ltd., based in Nanjing, is the applicant of record for K252494.

How long did the K252494 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Dec 5, 2025, 119 days later.

← All decisions in December 2025

Sources