MQK · Class II · 21 CFR 884.6160

FDA Product Code MQK: Labware, Assisted Reproduction

Leading manufacturers include Origio A/S, Becton Dickinson Labware and Vitrolife Sweden AB.

53
Total
53
Cleared
184d
Avg days
1999
Since
Growing category - 6 submissions in the last 2 years vs 4 in the prior period
Consistent review times: 188d avg (recent)

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

53 devices
1–24 of 53
Cleared Oct 30, 2026
Pleiades Device
K262066
My123Baby Medical Limited Dba Boost Fertility
Obstetrics & Gynecology · 130d
Cleared Oct 26, 2026
Cyperus
K262276
Contrario Medical, Inc.
Obstetrics & Gynecology · 112d
Cleared Oct 09, 2026
Fertilis microICSI Device
K262090
Fertilis Pty, Ltd.
Obstetrics & Gynecology · 109d
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
Cleared Jun 30, 2017
iVitri EZ
K162640
Reprobitech Corp.
Obstetrics & Gynecology · 281d
Cleared Feb 16, 2017
VitriGuard
K162833
Origio A/S
Obstetrics & Gynecology · 128d
Cleared Dec 14, 2016
Cryotec
K162051
Reprolife, Inc.
Obstetrics & Gynecology · 142d
Cleared Mar 14, 2016
Cryotop US
K153027
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 150d

About Product Code MQK - Regulatory Context

510(k) Submission Activity

53 total 510(k) submissions under product code MQK since 1999, with 53 receiving FDA clearance (average review time: 184 days).

Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MQK Product Code

FDA review times for MQK submissions have been consistent, averaging 188 days recently vs 183 days historically.

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