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The Tracker / October 2026 / K262214

510(k) cleared

Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)

Guangzhou Aimooe Technology Co., Ltd. · Oct 15, 2026 · K262214

FDA cleared the Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) from Guangzhou Aimooe Technology Co., Ltd. on Oct 15, 2026 under K262214, a traditional 510(k). The device falls under product code HAW, Neurological Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 30, 2026. The decision came 107 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 Guangzhou Aimooe Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262214?

K262214 is the FDA 510(k) for Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S), submitted by Guangzhou Aimooe Technology Co., Ltd.. FDA's decision date was Oct 15, 2026, under product code HAW (Neurological Stereotaxic Instrument).

Who makes the Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)?

Guangzhou Aimooe Technology Co., Ltd., based in Guangzhou, is the applicant of record for K262214.

How long did the K262214 review take?

FDA received the submission on Jun 30, 2026 and issued its decision on Oct 15, 2026, 107 days later.

← All decisions in October 2026