MQL · Class II · 21 CFR 884.6180

FDA Product Code MQL: Media, Reproductive

Leading manufacturers include Irvine Scientific Sales Co., Inc., Vitrolife Sweden AB and Medicult A/S.

260
Total
260
Cleared
158d
Avg days
1987
Since
Stable submission activity - 15 submissions in the last 2 years
Review times increasing: avg 195d recently vs 156d historically

FDA 510(k) Cleared Media, Reproductive Devices (Product Code MQL)

260 devices
1–24 of 260
Cleared Aug 28, 2026
Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK
K254261
CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.
Obstetrics & Gynecology · 241d
Cleared Apr 28, 2026
Ultra-Fast Warm
K260248
Kitazato Corporation
Obstetrics & Gynecology · 91d
Cleared Feb 20, 2026
CaseBio™ Culture w/HSA (CMH5)
K252672
Casebioscience, Inc.
Obstetrics & Gynecology · 179d
Cleared Sep 12, 2025
Fast Warm - NX
K250445
Fujifilm Irvine Scientific
Obstetrics & Gynecology · 210d
Cleared Aug 27, 2025
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]
K251637
Donnevie Medical Technology (Shanghai) Co. , Ltd.
Obstetrics & Gynecology · 90d
Cleared Aug 26, 2025
Ultra-Fast Vitri
K251305
Kitazato Corporation
Obstetrics & Gynecology · 120d
Cleared May 30, 2025
FertiCult Flushing medium
K242640
Fertipro NV
Obstetrics & Gynecology · 269d
Cleared Apr 10, 2025
Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
K242089
Jiangsu Ruifuda Medical Device Co., Ltd.
Obstetrics & Gynecology · 267d
Cleared Apr 10, 2025
Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
K242561
Donnevie Medical Technology (Shanghai) Co. , Ltd.
Obstetrics & Gynecology · 225d
Cleared Mar 21, 2025
V-GRAD
K241833
Vitromed GmbH
Obstetrics & Gynecology · 269d
Cleared Mar 21, 2025
CaseMONO™ Culture (CMON)
K242107
Casebioscience, Inc.
Obstetrics & Gynecology · 246d
Cleared Jan 08, 2025
Sperm Freezing Medium
K242043
Gimbo Medical Technology Shenzhen Co., Ltd.
Obstetrics & Gynecology · 180d
Cleared Dec 18, 2024
ARTSMedia Semen Wash Medium
K241095
Artsmedia Denmark Aps
Obstetrics & Gynecology · 240d
Cleared Dec 18, 2024
ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
K241132
Artsmedia Denmark Aps
Obstetrics & Gynecology · 238d
Cleared Nov 22, 2024
Giftlife® Single-Step Medium Plus
K242968
Gimbo Medical Technology Shenzhen Co., Ltd.
Obstetrics & Gynecology · 57d
Cleared Sep 13, 2024
V-VITFREEZE and V-VITWARM
K240176
Vitromed GmbH
Obstetrics & Gynecology · 234d
Cleared Aug 27, 2024
Vitrification Solution Set and Warming Solution Set
K233846
Ecmpc, LLC
Obstetrics & Gynecology · 267d
Cleared Aug 07, 2024
Ultra RapidWarm™ Blast
K240605
Vitrolife Sweden AB
Obstetrics & Gynecology · 156d
Cleared Jul 01, 2024
Cryo-straw (Type I, Type III)
K233477
Shandong Wego Ruisheng Medical Device Co., Ltd.
Obstetrics & Gynecology · 249d
Cleared Jun 13, 2024
Giftlife™ Fertilization Medium
K240149
Gimbo Medical Technology Shenzhen Co., Ltd.
Obstetrics & Gynecology · 146d
Cleared May 10, 2024
Oocyte Flushing & Retrieval Medium
K234023
Gimbo Medical Technology Shenzhen Co., Ltd.
Obstetrics & Gynecology · 142d
Cleared Apr 24, 2024
SSS-NX (Serum Substitute Supplement-NX)
K233764
Fujifilm Irvine Scientific
Obstetrics & Gynecology · 152d
Cleared Mar 20, 2024
V-PVP
K232125
Vitromed GmbH
Obstetrics & Gynecology · 247d
Cleared Jan 30, 2024
G-Vitri™ Vitrification Freeze Media
K232942
Gimbo Medical Technology Shenzhen Co., Ltd.
Obstetrics & Gynecology · 132d

About Product Code MQL - Regulatory Context

510(k) Submission Activity

260 total 510(k) submissions under product code MQL since 1987, with 260 receiving FDA clearance (average review time: 158 days).

Submission volume has remained relatively stable over the observed period, with 15 submissions in the last 24 months.

FDA 510(k) Review Time - MQL Product Code

Recent submissions under MQL have taken an average of 195 days to reach a decision - up from 156 days historically. Manufacturers should account for longer review timelines in current project planning.

MQL devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →