MQK · Class II · 21 CFR 884.6160

FDA Product Code MQK: Labware, Assisted Reproduction

Leading manufacturers include Origio A/S, Gimbo Medical Technology Shenzhen Co., Ltd. and Fujifilm Irvine Scientific.

50
Total
50
Cleared
188d
Avg days
1999
Since
Stable submission activity - 4 submissions in the last 2 years
Review times increasing: avg 229d recently vs 185d historically

FDA 510(k) Cleared Labware, Assisted Reproduction Devices (Product Code MQK)

50 devices
1–24 of 50
Cleared Feb 20, 2025
SperSort™ Sperm Sorting Chip (IPG02)
K241626
Ipreg Incorporation
Obstetrics & Gynecology · 259d
Cleared Feb 03, 2025
Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
K241454
Guangzhou Hehong Biotech Co., Ltd.
Obstetrics & Gynecology · 257d
Cleared Jan 31, 2025
SwimCount® Harvester (1 mL)
K241348
Motilitycount Aps
Obstetrics & Gynecology · 263d
Cleared Sep 26, 2024
cryo-GO Vitrification Device
K241341
Fujifilm Irvine Scientific
Obstetrics & Gynecology · 136d
Cleared Jun 14, 2024
G-Vitri™ Vitrification Straw
K240002
Gimbo Medical Technology Shenzhen Co., Ltd.
Obstetrics & Gynecology · 164d
Cleared Mar 14, 2024
SpermAlign Sperm Separation Device
K232980
Cytoswim, Ltd.
Obstetrics & Gynecology · 175d
Cleared Mar 08, 2024
Nest VT Vitrification Device
K233177
Cook Incorporated
Obstetrics & Gynecology · 162d
Cleared Oct 31, 2022
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
K221810
Bonraybio Co., Ltd.
Obstetrics & Gynecology · 131d
Cleared Mar 11, 2022
EmbryoSlide+ ic8 dish
K213869
Vitrolife A/S
Obstetrics & Gynecology · 88d
Cleared Jun 04, 2021
SureStrip Vitrification Straw, SureLock Vitrification Straw
K203626
Allwin Medical Devices, Inc.
Obstetrics & Gynecology · 175d
Cleared Dec 16, 2020
Pasteur Pipette 3mL, Pasteur Pipette 1mL
K201213
Hertart Aps
Obstetrics & Gynecology · 225d
Cleared Jun 25, 2020
VitriGuard
K200815
Origio A/S
Obstetrics & Gynecology · 87d
Cleared Jan 04, 2019
Rapid-i™ Kit
K181461
Vitrolife Sweden AB
Obstetrics & Gynecology · 214d
Cleared Nov 09, 2018
Cryotop®US-flash and Cryotop®US-scoop
K181469
Kitazato Corporation
Obstetrics & Gynecology · 158d
Cleared May 04, 2018
VitriGuard
K180740
Origio A/S
Obstetrics & Gynecology · 43d
Cleared Mar 08, 2018
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
K173075
Dxnow, Inc.
Obstetrics & Gynecology · 160d
Cleared Feb 09, 2018
iVitri Straw
K172751
Reprobitech Corp.
Obstetrics & Gynecology · 150d

About Product Code MQK - Regulatory Context

510(k) Submission Activity

50 total 510(k) submissions under product code MQK since 1999, with 50 receiving FDA clearance (average review time: 188 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - MQK Product Code

Recent submissions under MQK have taken an average of 229 days to reach a decision - up from 185 days historically. Manufacturers should account for longer review timelines in current project planning.

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