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The Tracker / August 2026 / K260643

510(k) cleared

Cimilre Dual Max

Cimilre Co., Ltd. · Aug 21, 2026 · K260643

FDA cleared the Cimilre Dual Max from Cimilre Co., Ltd. on Aug 21, 2026 under K260643, a traditional 510(k). The device falls under product code HGX, Pump, Breast, Powered, regulated at 21 CFR 884.5160 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Feb 27, 2026. The decision came 175 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 Cimilre Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260643?

K260643 is the FDA 510(k) for Cimilre Dual Max, submitted by Cimilre Co., Ltd.. FDA's decision date was Aug 21, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Cimilre Dual Max?

Cimilre Co., Ltd., based in Cheonan-Si, Chungcheongnam-Do,, is the applicant of record for K260643.

How long did the K260643 review take?

FDA received the submission on Feb 27, 2026 and issued its decision on Aug 21, 2026, 175 days later.

← All decisions in August 2026