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FDA 510(k)

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)

K-Number: K242089 · 2025-04-10

ApplicantJiangsu Ruifuda Medical Device Co., Ltd.
Decision Date2025-04-10
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Ruifuda Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K242089. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)?

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Jiangsu Ruifuda Medical Device Co., Ltd.. The 510(k) number is K242089.

When did Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) receive FDA 510(k) clearance?

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) received FDA 510(k) clearance on 2025-04-10, under 510(k) number K242089.

Who is the listed applicant for Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)?

The FDA 510(k) record lists Jiangsu Ruifuda Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)?

The FDA product code for Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) is MQL.

Related Devices (Code: MQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato CorporationK242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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