Vitrifreeze Medium; Vitrithaw Medium

FDA 510(k) K070135 · Fertipro NV

Substantially Equivalent

510(k) numberK070135

Submission

Device name
Vitrifreeze Medium; Vitrithaw Medium
Applicant
Fertipro NV
Irvine, CA, US
Received
January 16, 2007
Decision date
August 16, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQL – Media, Reproductive
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6180
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code MQL

510(k)DeviceApplicantDecision
K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)MQL · Traditional Cell Store (Beijing) Biotechnology Co., Ltd.08/28/2026SE
K260248Ultra-Fast WarmMQL · Traditional Kitazato Corporation04/28/2026SE
K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)MQL · Traditional Casebioscience, Inc.02/20/2026SE
K250445Fast Warm - NXMQL · Traditional Fujifilm Irvine Scientific09/12/2025SE
K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…MQL · Traditional Donnevie Medical Technology (Shanghai) Co. , Ltd.08/27/2025SE
K251305Ultra-Fast Vitri; Ultra-Fast WarmMQL · Traditional Kitazato Corporation08/26/2025SE
K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinMQL · Traditional Fertipro NV05/30/2025SE
K242561Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)MQL · Traditional Donnevie Medical Technology (Shanghai) Co. , Ltd.04/10/2025SE
K242089Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)MQL · Traditional Jiangsu Ruifuda Medical Device Co., Ltd.04/10/2025SE
K242107CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC)…MQL · Traditional Casebioscience, Inc.03/21/2025SE

More from Casebioscience, Inc.

510(k)DeviceDecision
K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinMQL · Traditional 05/30/2025SE
K221547InActiv BlueQBD · Traditional 06/11/2024SE
K053494Oil for Tissue Culture, Gradient System and SpermfreezeMQL · Traditional 03/23/2006SE

Questions and answers

When was Vitrifreeze Medium; Vitrithaw Medium cleared by the FDA?

Vitrifreeze Medium; Vitrithaw Medium (K070135) received a 510(k) decision of Substantially Equivalent on August 16, 2007, 212 days after the submission was received.

What is the product code of K070135?

The FDA product code is MQL – Media, Reproductive, a Class II (moderate risk) device regulated under 21 CFR 884.6180.