ARTSMedia In Vitro Culture Medium (AM-IVC Medium)

FDA 510(k) K220715 · Artsmedia Denmark Aps

Substantially Equivalent

510(k) numberK220715

Submission

Device name
ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
Applicant
Artsmedia Denmark Aps
Virum, DK
Received
March 11, 2022
Decision date
February 10, 2023
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

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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
K241132ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)MQL · Traditional 12/18/2024SE
K241095ARTSMedia Semen Wash MediumMQL · Traditional 12/18/2024SE

Questions and answers

When was ARTSMedia In Vitro Culture Medium (AM-IVC Medium) cleared by the FDA?

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) (K220715) received a 510(k) decision of Substantially Equivalent on February 10, 2023, 336 days after the submission was received.

What is the product code of K220715?

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