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The Tracker / August 2026 / K254261

510(k) cleared

Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)

CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. · Aug 28, 2026 · K254261

FDA cleared the Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) from CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. on Aug 28, 2026 under K254261, a traditional 510(k). The device falls under product code MQL, Media, Reproductive, regulated at 21 CFR 884.6180 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Dec 30, 2025. The decision came 241 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 CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254261?

K254261 is the FDA 510(k) for Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK), submitted by CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.. FDA's decision date was Aug 28, 2026, under product code MQL (Media, Reproductive).

Who makes the Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)?

CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD., based in Beijing, is the applicant of record for K254261.

How long did the K254261 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on Aug 28, 2026, 241 days later.

← All decisions in August 2026