Product Code: MQK FDA class 2 21 CFR 884.6160

Labware, Assisted Reproduction

Obstetrics/Gynecology

Labware for Assisted Reproduction encompasses obstetrics/gynecology devices such as dishes, plates, tubes, and containers specifically designed and manufactured for use in ART laboratories to culture and handle gametes and embryos. Classified as FDA Class 2 under 21 CFR 884.6160, this labware requires 510(k) premarket notification. The product code is MQK, and it is eligible for third-party 510(k) review.

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Basic Information

Product Code: MQK
Device Class: FDA class 2
Regulation Number: 884.6160
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 50 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241626	SperSort Sperm Sorting Chip (IPG02)	Feb 20, 2025	Substantially Equivalent	Ipreg Incorporation
K241454	Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)	Feb 03, 2025	Substantially Equivalent	Guangzhou Hehong Biotech Co., Ltd.
K241348	SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)	Jan 31, 2025	Substantially Equivalent	Motilitycount Aps
K241341	cryo-GO Vitrification Device	Sep 26, 2024	Substantially Equivalent	Fujifilm Irvine Scientific
K240002	G-Vitri Vitrification Straw	Jun 14, 2024	Substantially Equivalent	Gimbo Medical Technology Shenzhen Co., Ltd.
K232980	SpermAlign Sperm Separation Device	Mar 14, 2024	Substantially Equivalent	Cytoswim, Ltd.
K233177	Nest VT Vitrification Device	Mar 08, 2024	Substantially Equivalent	Cook Incorporated
K221810	LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device	Oct 31, 2022	Substantially Equivalent	Bonraybio Co., Ltd.
K213869	EmbryoSlide+ ic8 dish	Mar 11, 2022	Substantially Equivalent	Vitrolife A/S
K203626	SureStrip Vitrification Straw, SureLock Vitrification Straw	Jun 04, 2021	Substantially Equivalent	Allwin Medical Devices, Inc.
K201213	Pasteur Pipette 3mL, Pasteur Pipette 1mL	Dec 16, 2020	Substantially Equivalent	Hertart Aps
K200815	VitriGuard	Jun 25, 2020	Substantially Equivalent	Origio A/S
K181461	Rapid-i Kit	Jan 04, 2019	Substantially Equivalent	Vitrolife Sweden AB
K181469	Cryotop®US-flash and Cryotop®US-scoop	Nov 09, 2018	Substantially Equivalent	Kitazato Corporation
K180740	VitriGuard	May 04, 2018	Substantially Equivalent	Origio A/S
K173075	ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)	Mar 08, 2018	Substantially Equivalent	Dxnow, Inc.
K172751	iVitri Straw	Feb 09, 2018	Substantially Equivalent	Reprobitech Corp.
K162640	iVitri EZ	Jun 30, 2017	Substantially Equivalent	Reprobitech Corp.
K162833	VitriGuard	Feb 16, 2017	Substantially Equivalent	Origio A/S
K162051	Cryotec	Dec 14, 2016	Substantially Equivalent	Reprolife, Inc.
K153027	Cryotop US	Mar 14, 2016	Substantially Equivalent	Kitazato Biopharma Co., Ltd.
K150961	EmbryoSlide Culture Dish	Dec 04, 2015	Substantially Equivalent	Vitrolife A/S
K150756	Micro well group culture dish, 9-well; Micro well group culture dish, 16-well	Jul 20, 2015	Substantially Equivalent	Hertart
K140207	RAPID-I KIT	Dec 18, 2014	Substantially Equivalent	Vitrolife Sweden AB
K141663	EEVA DISH (WITH 12 MICROWELLS)	Jul 22, 2014	Substantially Equivalent	Auxogyn, Inc.
K133295	QUALIS	Jun 18, 2014	Substantially Equivalent	Menicon Co., Ltd. New Business Division
K140072	CRYOTOP(R) SC	Apr 03, 2014	Substantially Equivalent	Kitazato Biopharma Co., Ltd.
K131145	PROINSERT	Feb 20, 2014	Substantially Equivalent	Nidacon International AB
K122982	CRYOLOCK	Jan 09, 2014	Substantially Equivalent	Biotech, Inc.
K123641	CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH	Jul 03, 2013	Substantially Equivalent	Hertart
K112644	SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM	Dec 19, 2012	Substantially Equivalent	Lotus Bio, Ltd.
K112695	CRYOTOP	Dec 12, 2012	Substantially Equivalent	Kitazato Biopharma Co;Ltd
K112413	RI MSC (MIGRATION SEDIMENTATION CHAMBER)	Jul 13, 2012	Substantially Equivalent	Research Instruments , Ltd.
K103028	EEVATM PETRI DISH	Aug 11, 2011	Substantially Equivalent	Auxogyn, Inc.
K100596	CRYOPETTE	Dec 06, 2010	Substantially Equivalent	Mid-Atlantic Diagnostics, Inc.
K092398	HSV STRAW	Oct 06, 2010	Substantially Equivalent	Cryo Bio System
K090832	RAPID-I	Dec 23, 2009	Substantially Equivalent	Vitrolife Sweden AB
K090429	NUNC IVF CENTERWELL AND ICSI DISHES	Sep 18, 2009	Substantially Equivalent	Thermo Fisher Scientific (Nalge Nunc Intl)
K081896	BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH	Aug 20, 2008	Substantially Equivalent	Biogenics, Inc.
K080395	SUNIVF DISHES	Aug 13, 2008	Substantially Equivalent	<Genx> Intl., Inc.
K070047	NUNC IVF DISHES AND NUNC IVF 4-WELL DISH	May 18, 2007	Substantially Equivalent	Nunc A/S
K052457	PICSI SPERM SELECTION DEVICE	Apr 13, 2006	Substantially Equivalent	Biocoat, Inc.
K040717	NUNC IVF MULTIDISH 4 WELLS NUNCLON	Aug 12, 2004	Substantially Equivalent	Nunc A/S
K000915	PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75	May 12, 2000	Substantially Equivalent	Humagen Fertility Diagnostics, Inc.
K994361	ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL	Feb 18, 2000	Substantially Equivalent	Genesis Industries, Inc.
K993881	GENX CULTURE DISH	Feb 14, 2000	Substantially Equivalent	<Genx> Intl., Inc.
K990941	NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L	Jul 14, 1999	Substantially Equivalent	Humagen Fertility Diagnostics, Inc.
K991253	FALCON IVF ROUND DISH	May 05, 1999	Substantially Equivalent	Becton Dickinson Labware
K991251	FALCON IVF ONE WELL DISH	May 05, 1999	Substantially Equivalent	Becton Dickinson Labware
K991249	FALCON IVF FOUR WELL PLATE	May 05, 1999	Substantially Equivalent	Becton Dickinson Labware