Product Code: MQF FDA class 2 21 CFR 884.6110

Catheter, Assisted Reproduction

Obstetrics/Gynecology

The Assisted Reproduction Catheter is an obstetrics/gynecology device used in ART procedures such as embryo transfer or intrauterine insemination, designed for the gentle and precise delivery of gametes or embryos into the uterine cavity. Classified as FDA Class 2 under 21 CFR 884.6110, it requires 510(k) premarket notification. The product code is MQF, and it is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code MQF in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: MQF
Device Class: FDA class 2
Regulation Number: 884.6110
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 53 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253354	Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)	Feb 12, 2026	Substantially Equivalent	Guangzhou Hehong Biotech Co., Ltd.
K243373	Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)	Jul 23, 2025	Substantially Equivalent	Vitrolife Sweden AB
K240307	VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)	Aug 16, 2024	Substantially Equivalent	Shenzhen Vitavitro Biotech Co., Ltd.
K231730	FemaSeed Intratubal Insemination	Sep 22, 2023	Substantially Equivalent	Femasys, Inc.
K220010	Daylily Single Use Sterile Embryo Transfer Catheter	Dec 16, 2022	Substantially Equivalent	Shanghai Horizon Medical Technology Co., Ltd.
K200248	Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators	Jul 01, 2020	Substantially Equivalent	Allwin Medical Devices, Inc.
K192540	Kitazato ET Catheters	May 01, 2020	Substantially Equivalent	Kitazato Corporation
K190522	Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)	Nov 14, 2019	Substantially Equivalent	Allwin Medical Devices, Inc.
K191015	Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)	May 17, 2019	Substantially Equivalent	Cook Incorporated
K180302	Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter	Oct 24, 2018	Substantially Equivalent	Cook Incorporated
K173431	Towako Transmyometrial Embryo Transfer Set	May 18, 2018	Substantially Equivalent	William A. Cook Australia Pty. , Ltd.
K173103	Pivet and Soft-Pass Embryo Transfer Catheter Sets	Apr 13, 2018	Substantially Equivalent	Cook Incorporated
K173686	Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter	Apr 11, 2018	Substantially Equivalent	Cook Incorporated
K172051	Guardia Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter	Jan 10, 2018	Substantially Equivalent	Cook Incorporated
K172321	Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters	Dec 21, 2017	Substantially Equivalent	Cook Incorporated
K163318	Soules Intrauterine Insemination Catheter	Jul 14, 2017	Substantially Equivalent	Cook Incorporated
K162878	Kitazato ET Catheters	Jul 13, 2017	Substantially Equivalent	Kitazato Corporation
K162667	Kitazato IUI Catheter	May 11, 2017	Substantially Equivalent	Kitazato Corporation
K161547	Transem and EchoGen Embryo Transfer Catheters	Mar 09, 2017	Substantially Equivalent	Origio A/S
K162064	CrossBay IVF Embryo Transfer Catheter Set	Jan 05, 2017	Substantially Equivalent	Crossbay Medical, Inc.
K143669	MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter	Nov 23, 2015	Substantially Equivalent	Medgyn Products, Inc.
K141666	FERTILIGENT SLOW RELEASE IUI CATHETER KIT	Feb 03, 2015	Substantially Equivalent	Fertiligent, Ltd.
K131491	KITAZATO IUI CATHETER	Sep 11, 2013	Substantially Equivalent	Kitazato Medical Co., Ltd.
K112396	IUI CATHETERS	Nov 02, 2012	Substantially Equivalent	Kitazato Medical Co., Ltd.
K120154	INTRAUTERINE INSEMINATION (IUI) CATHETER	Mar 21, 2012	Substantially Equivalent	Catheter Research, Inc.
K092579	INTRAUTERINE INSEMINATION (IUI) CATHETER	Apr 02, 2010	Substantially Equivalent	Fertiligent, Ltd.
K053208	CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET	Jan 30, 2006	Substantially Equivalent	Swemed Lab International AB
K052059	IUI CATHETER, MODEL 9057	Nov 22, 2005	Substantially Equivalent	Inntec, Inc.
K050521	EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S	May 02, 2005	Substantially Equivalent	Inntec, Inc.
K041470	MORTON IUI CATHETERS	Nov 22, 2004	Substantially Equivalent	Fertility Technology Resources, Inc.
K033084	WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER	Dec 19, 2003	Substantially Equivalent	Portex , Ltd.
K023382	COOPERSURGICAL MALLEABLE SYTLET	Dec 20, 2002	Substantially Equivalent	Cooper Surgical
K023384	COOPERSURGICAL TRIAL TRANSFER CATHETER	Dec 13, 2002	Substantially Equivalent	Cooper Surgical
K023383	COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER	Dec 13, 2002	Substantially Equivalent	Cooper Surgical
K023017	TUCKER EMBRYO CATHETER	Dec 13, 2002	Substantially Equivalent	Fertility Technology Resources, Inc.
K023379	COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER	Dec 11, 2002	Substantially Equivalent	Cooper Surgical
K013536	EMTRAC; DELPHIN; SEMTRAC 2000 SET	Nov 30, 2001	Substantially Equivalent	Gynetics Medical Products NV
K013501	IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B	Nov 30, 2001	Substantially Equivalent	Gynetics Medical Products NV
K012220	TAO EMBRYO TRANSFER CATHETER SYSTEM	Aug 27, 2001	Substantially Equivalent	Ttj Biomedical, LLC
K000950	EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201	May 12, 2000	Substantially Equivalent	Labotect Labor-Technik Gottingen
K000656	EMBRYON GIFT TRANSFER CATHETERS/SETS	Mar 09, 2000	Substantially Equivalent	Rocket Medical Plc
K994327	EMBRYON TRANSFER CATHETERS/SETS	Feb 28, 2000	Substantially Equivalent	Rocket Medical Plc
K992307	EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER	Sep 13, 1999	Substantially Equivalent	Fertility Technology Resources, Inc.
K991266	<GENX> EMBRYO TRANSFER CATHETER CC GLIDER	Sep 09, 1999	Substantially Equivalent	<Genx> Intl., Inc.
K990350	WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316	Jul 26, 1999	Substantially Equivalent	CooperSurgical, Inc.
K990349	WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST	Jul 26, 1999	Substantially Equivalent	CooperSurgical, Inc.
K990348	WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N	Jul 26, 1999	Substantially Equivalent	CooperSurgical, Inc.
K983604	INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER	May 27, 1999	Substantially Equivalent	Washington Regulatory Services
K983595	TRANSMYOMETRIAL EMBRYO TRANSFER SET	Feb 08, 1999	Substantially Equivalent	Cook Ob/Gyn
K983594	EMBRYO TRANSFER CATHETERS/SETS	Dec 21, 1998	Substantially Equivalent	Cook Ob/Gyn
K983591	INTRATUBAL TRANSFER SETS	Dec 21, 1998	Substantially Equivalent	Cook Ob/Gyn
K983590	GIFT CATHETER SET/S	Dec 21, 1998	Substantially Equivalent	Cook Ob/Gyn
K983587	HYSTEROSCOPIC GIFT CATHETER SETS	Dec 16, 1998	Substantially Equivalent	Cook Ob/Gyn