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The Tracker / August 2026 / K260481

510(k) cleared

GC85A

Samsung Electronics Co., Ltd. · Aug 27, 2026 · K260481

FDA cleared the GC85A from Samsung Electronics Co., Ltd. on Aug 27, 2026 under K260481, a traditional 510(k). The device falls under product code KPR, System, X-Ray, Stationary, regulated at 21 CFR 892.1680 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 13, 2026. The decision came 195 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Samsung Electronics Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K261187 (Hearing Aid Feature), K261011 (Sleep Apnea Feature (v2.0)).

Questions & Answers

What did FDA clear under K260481?

K260481 is the FDA 510(k) for GC85A, submitted by Samsung Electronics Co., Ltd.. FDA's decision date was Aug 27, 2026, under product code KPR (System, X-Ray, Stationary).

Who makes the GC85A?

Samsung Electronics Co., Ltd., based in Suwon-Si, is the applicant of record for K260481.

How long did the K260481 review take?

FDA received the submission on Feb 13, 2026 and issued its decision on Aug 27, 2026, 195 days later.

← All decisions in August 2026

Sources