MQG · Class II · 21 CFR 884.6120

FDA Product Code MQG: Accessory, Assisted Reproduction

Leading manufacturers include Zander Medical Supplies, Inc., Unisense Fertilitech A/S and Intl., Inc..

47
Total
47
Cleared
165d
Avg days
1998
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 165d avg (recent)

FDA 510(k) Cleared Accessory, Assisted Reproduction Devices (Product Code MQG)

47 devices
1–24 of 47
Cleared Aug 19, 2026
Wallace® Aspiration Pump (WAPV1)
K261083
CooperSurgical, Inc.
Obstetrics & Gynecology · 140d
Cleared Apr 28, 2026
Vacuum Pump (Model: AD-VPUM-500)
K260194
Sheng Sheng Yi (Beijing) Technology Company Limited
Obstetrics & Gynecology · 96d
Cleared May 22, 2025
Harioculture TL-16 Time-lapse Incubator
K242684
Hua Yue Medical Technology Co., Ltd.
Obstetrics & Gynecology · 258d
Cleared May 07, 2024
Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
K232493
Wuhan Huchuang Union Technology Co., Ltd.
Obstetrics & Gynecology · 264d
Cleared Jun 07, 2018
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
K180188
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 135d
Cleared May 11, 2018
EmbryoScope+
K173264
Vitrolife A/S
Obstetrics & Gynecology · 212d
Cleared Apr 20, 2018
Geri Embryo Incubator and Geri Dish
K180304
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 77d
Cleared Nov 15, 2017
Geri Embryo Incubator and Geri Dish
K171736
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 156d
Cleared Jun 13, 2017
COOK Vacuum Pump
K160753
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 452d
Cleared Jul 18, 2016
RI Witness Embryology Heated Plate
K160504
Research Instruments Limited
Obstetrics & Gynecology · 145d
Cleared Apr 22, 2016
MIRI TL
K151357
At Medical Uab
Obstetrics & Gynecology · 338d
Cleared Aug 08, 2014
EMBRYOVIEWER SOFTWARE
K133712
Unisense Fertilitech A/S
Obstetrics & Gynecology · 246d
Cleared May 07, 2014
Origio Gas Line Filter
K132870
Origio, Inc.
Obstetrics & Gynecology · 236d
Cleared Apr 23, 2014
XQ-1 INCUBATOR
K133742
At Medical Uab
Obstetrics & Gynecology · 135d
Cleared Nov 29, 2012
PLANER BT37 INCUBATOR
K121566
Planer Plc
Obstetrics & Gynecology · 184d
Cleared Dec 21, 2011
EMBRYO VIEWER SOFTWARE
K113075
Unisense Fertilitech A/S
Obstetrics & Gynecology · 65d
Cleared Aug 11, 2011
EMBRYOSCOPE
K111715
Unisense Fertilitech A/S
Obstetrics & Gynecology · 52d
Cleared Feb 08, 2011
HEAL FORCE CO2 INCUBATOR
K101988
Shanghai Lishen Scientific Equipment Co., Ltd.
Obstetrics & Gynecology · 209d
Cleared Jan 11, 2011
EMBRYOSCOPE AND EMBRYOSLIDE
K092183
Unisense Fertilitech A/S
Obstetrics & Gynecology · 539d
Cleared Oct 06, 2006
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
K050197
Minitube of America, Inc.
Obstetrics & Gynecology · 617d
Cleared Sep 08, 2005
ZIVF-AIRE
K041952
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 415d
Cleared Aug 27, 2003
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
K030525
Mid-Atlantic Diagnostics, Inc.
Obstetrics & Gynecology · 189d
Cleared Mar 10, 2003
KENDRO HERACELL 240 INCUBATOR
K023465
Kendro Laboratory Products, L.P.
Obstetrics & Gynecology · 146d
Cleared Aug 15, 2002
DB1 EMBRYO FREEZE
K011327
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 471d

About Product Code MQG - Regulatory Context

510(k) Submission Activity

47 total 510(k) submissions under product code MQG since 1998, with 47 receiving FDA clearance (average review time: 165 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MQG Product Code

FDA review times for MQG submissions have been consistent, averaging 165 days recently vs 165 days historically.

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