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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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.

This is the only decision on file for Nanjing Kangni Smart Technology Co., Ltd. in the last 12 months of the tracker.

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