ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)

FDA 510(k) K241132 · Artsmedia Denmark Aps

Substantially Equivalent

510(k) numberK241132

Submission

Device name
ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
Applicant
Artsmedia Denmark Aps
Virum, DK
Received
April 24, 2024
Decision date
December 18, 2024
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
K241095ARTSMedia Semen Wash MediumMQL · Traditional 12/18/2024SE
K220715ARTSMedia In Vitro Culture Medium (AM-IVC Medium)MQL · Traditional 02/10/2023SE

Questions and answers

When was ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) cleared by the FDA?

ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) (K241132) received a 510(k) decision of Substantially Equivalent on December 18, 2024, 238 days after the submission was received.

What is the product code of K241132?

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