Product Code: MQG FDA class 2 21 CFR 884.6120

Accessory, Assisted Reproduction

Obstetrics/Gynecology

Accessories for Assisted Reproduction are obstetrics/gynecology devices used in conjunction with ART procedures to support gamete and embryo handling, transfer, and related steps in reproductive technology. Classified as FDA Class 2 under 21 CFR 884.6120, they require 510(k) premarket notification. The product code is MQG, and these accessories are eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MQG
Device Class: FDA class 2
Regulation Number: 884.6120
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 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260194	Vacuum Pump (Model: AD-VPUM-500)	Apr 28, 2026	Substantially Equivalent	Sheng Sheng Yi (Beijing) Technology Company Limited
K242684	Harioculture TL-16 Time-lapse Incubator	May 22, 2025	Substantially Equivalent	Hua Yue Medical Technology Co., Ltd.
K232493	Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)	May 07, 2024	Substantially Equivalent	Wuhan Huchuang Union Technology Co., Ltd.
K180188	Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish	Jun 07, 2018	Substantially Equivalent	Genea Biomedx Pty, Ltd.
K173264	EmbryoScope+	May 11, 2018	Substantially Equivalent	Vitrolife A/S
K180304	Geri Embryo Incubator and Geri Dish	Apr 20, 2018	Substantially Equivalent	Genea Biomedx Pty, Ltd.
K171736	Geri Embryo Incubator and Geri Dish	Nov 15, 2017	Substantially Equivalent	Genea Biomedx Pty, Ltd.
K160753	COOK Vacuum Pump	Jun 13, 2017	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K160504	RI Witness Embryology Heated Plate	Jul 18, 2016	Substantially Equivalent	Research Instruments Limited
K151357	MIRI TL	Apr 22, 2016	Substantially Equivalent	At Medical Uab
K133712	EMBRYOVIEWER SOFTWARE	Aug 08, 2014	Substantially Equivalent	Unisense Fertilitech A/S
K132870	Origio Gas Line Filter	May 07, 2014	Substantially Equivalent	Origio, Inc.
K133742	XQ-1 INCUBATOR	Apr 23, 2014	Substantially Equivalent	At Medical Uab
K121566	PLANER BT37 INCUBATOR	Nov 29, 2012	Substantially Equivalent	Planer Plc
K113075	EMBRYO VIEWER SOFTWARE	Dec 21, 2011	Substantially Equivalent	Unisense Fertilitech A/S
K111715	EMBRYOSCOPE	Aug 11, 2011	Substantially Equivalent	Unisense Fertilitech A/S
K101988	HEAL FORCE CO2 INCUBATOR	Feb 08, 2011	Substantially Equivalent	Shanghai Lishen Scientific Equipment Co., Ltd.
K092183	EMBRYOSCOPE AND EMBRYOSLIDE	Jan 11, 2011	Substantially Equivalent	Unisense Fertilitech A/S
K050197	MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045	Oct 06, 2006	Substantially Equivalent	Minitube of America, Inc.
K041952	ZIVF-AIRE	Sep 08, 2005	Substantially Equivalent	Zander Medical Supplies, Inc.
K032086	KRYO ART CONTROLLED RATE FREEZER	Mar 19, 2004	Substantially Equivalent	Planer Plc
K032526	BINDER CO2 INCUBATOR SERIE CB	Aug 29, 2003	Substantially Equivalent	Binder GmbH
K030525	CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-2436, WKST-2448, WKST-2460, WKST-2472 AND WKST-24*72D PLUS ACCESSORIES	Aug 27, 2003	Substantially Equivalent	Mid-Atlantic Diagnostics, Inc.
K023465	KENDRO HERACELL 240 INCUBATOR	Mar 10, 2003	Substantially Equivalent	Kendro Laboratory Products, L.P.
K011327	DB1 EMBRYO FREEZE	Aug 15, 2002	Substantially Equivalent	Zander Medical Supplies, Inc.
K020560	WORKBENCH BY <GENX>	Jun 19, 2002	Substantially Equivalent	Genx Intl., Inc.
K021042	THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476	May 15, 2002	Substantially Equivalent	Thermo Forma, Inc.
K014160	PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)	Feb 08, 2002	Substantially Equivalent	Cook Urological, Inc.
K013703	SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M	Dec 14, 2001	Substantially Equivalent	Sanyo North America Corp.
K013401	K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01	Dec 14, 2001	Substantially Equivalent	K-Systems, Kivex Biotec , Ltd.
K002971	MTG - MINITUB HEATED STAGE SYSTEMS	Dec 15, 2000	Substantially Equivalent	Zander Medical Supplies, Inc.
K001600	<GENX> CODA INCUBATOR CELLMATE	Nov 22, 2000	Substantially Equivalent	<Genx> Intl., Inc.
K002961	MINITUB MULTI-PURPOSE CASSETTES	Nov 21, 2000	Substantially Equivalent	Zander Medical Supplies, Inc.
K003184	RS BIOTECH GALAXY 'R' CO2 INCUBATOR	Nov 20, 2000	Substantially Equivalent	Zander Medical Supplies, Inc.
K002595	CBS STRAW	Nov 17, 2000	Substantially Equivalent	Cryo Bio System
K002805	KENDRO HERACELL CO2 INCUBATOR	Nov 09, 2000	Substantially Equivalent	Kendro Laboratory Products, L.P.
K001486	GENX CODA AIR PURIFICATION SYSTEM	Sep 15, 2000	Substantially Equivalent	<Genx> Intl., Inc.
K001524	FORMA SCIENTIFIC DIRECT HEAT INCUBATORS	Jul 12, 2000	Substantially Equivalent	Thermoquest Corp.
K000394	CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT	Feb 29, 2000	Substantially Equivalent	Rocket Medical Plc
K992070	COOK ULTRA QUIET VACUUM PUMP & REGULATOR	Oct 27, 1999	Substantially Equivalent	Cook Urological, Inc.
K991216	HOFFMAN IVF-1	Aug 05, 1999	Substantially Equivalent	(Arms) Hoffman Surgical Equipment, Ivf Division
K991408	FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR	Jul 19, 1999	Substantially Equivalent	Thermoquest Corp.
K991263	THERMOPLATE	Jul 08, 1999	Substantially Equivalent	Tokai Hit Co., Ltd.
K991229	K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L	Jun 29, 1999	Substantially Equivalent	Henning Knudsen Engineering A/S
K983642	COOK MINI-INCUBATOR	Feb 01, 1999	Substantially Equivalent	Cook Ob/Gyn
K983609	COOK TEST TUBE HEATER	Dec 16, 1998	Substantially Equivalent	Cook Ob/Gyn