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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K260053

510(k) cleared

Power Wheelchair (OS-R-M01I)

Beijing OrionStar Technology Co., Ltd. · Sep 8, 2026 · K260053

FDA cleared the Power Wheelchair (OS-R-M01I) from Beijing OrionStar Technology Co., Ltd. on Sep 8, 2026 under K260053, 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 Jan 8, 2026. The decision came 243 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beijing OrionStar Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253952 (Power Wheelchair (OS-R-M01S)).

Questions & Answers

What did FDA clear under K260053?

K260053 is the FDA 510(k) for Power Wheelchair (OS-R-M01I), submitted by Beijing OrionStar Technology Co., Ltd.. FDA's decision date was Sep 8, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Power Wheelchair (OS-R-M01I)?

Beijing OrionStar Technology Co., Ltd., based in Beijing, is the applicant of record for K260053.

How long did the K260053 review take?

FDA received the submission on Jan 8, 2026 and issued its decision on Sep 8, 2026, 243 days later.

← All decisions in September 2026

Sources