MQG · Class II · 21 CFR 884.6120

FDA Product Code MQG: Accessory, Assisted Reproduction

Leading manufacturers include Intl., Inc., Cook Urological, Inc. and Genea Biomedx Pty, Ltd..

46
Total
46
Cleared
165d
Avg days
1998
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Consistent review times: 177d avg (recent)

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

46 devices
1–24 of 46
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 Jun 19, 2002
WORKBENCH BY
K020560
Intl., Inc.
Obstetrics & Gynecology · 119d
Cleared Feb 08, 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160
Cook Urological, Inc.
Obstetrics & Gynecology · 51d
Cleared Nov 22, 2000
CODA INCUBATOR CELLMATE
K001600
Intl., Inc.
Obstetrics & Gynecology · 182d
Cleared Sep 15, 2000
GENX CODA AIR PURIFICATION SYSTEM
K001486
Intl., Inc.
Obstetrics & Gynecology · 126d
Cleared Oct 27, 1999
COOK ULTRA QUIET VACUUM PUMP & REGULATOR
K992070
Cook Urological, Inc.
Obstetrics & Gynecology · 131d
Cleared Feb 01, 1999
COOK MINI-INCUBATOR
K983642
Cook Ob/Gyn
Obstetrics & Gynecology · 108d
Cleared Dec 16, 1998
COOK TEST TUBE HEATER
K983609
Cook Ob/Gyn
Obstetrics & Gynecology · 63d

About Product Code MQG - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code MQG since 1998, with 46 receiving FDA clearance (average review time: 165 days).

Submission volume has increased in recent years - 2 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 177 days recently vs 165 days historically.

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