MQF · Class II · 21 CFR 884.6110

FDA Product Code MQF: Catheter, Assisted Reproduction

Leading manufacturers include Cook Incorporated, Cook Ob/Gyn and CooperSurgical, Inc..

53
Total
53
Cleared
148d
Avg days
1998
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 201d recently vs 146d historically

FDA 510(k) Cleared Catheter, Assisted Reproduction Devices (Product Code MQF)

53 devices
1–24 of 53
Cleared Feb 12, 2026
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
K253354
Guangzhou Hehong Biotech Co., Ltd.
Obstetrics & Gynecology · 135d
Cleared Jul 23, 2025
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500)
K243373
Vitrolife Sweden AB
Obstetrics & Gynecology · 266d
Cleared Aug 16, 2024
VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
K240307
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 196d
Cleared Sep 22, 2023
FemaSeed Intratubal Insemination
K231730
Femasys, Inc.
Obstetrics & Gynecology · 101d
Cleared Dec 16, 2022
Daylily Single Use Sterile Embryo Transfer Catheter
K220010
Shanghai Horizon Medical Technology Co., Ltd.
Obstetrics & Gynecology · 346d
Cleared Jul 01, 2020
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
K200248
Allwin Medical Devices, Inc.
Obstetrics & Gynecology · 152d
Cleared May 01, 2020
Kitazato ET Catheters
K192540
Kitazato Corporation
Obstetrics & Gynecology · 228d
Cleared Nov 14, 2019
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)
K190522
Allwin Medical Devices, Inc.
Obstetrics & Gynecology · 255d
Cleared May 17, 2019
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)
K191015
Cook Incorporated
Obstetrics & Gynecology · 30d
Cleared Oct 24, 2018
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter
K180302
Cook Incorporated
Obstetrics & Gynecology · 264d
Cleared May 18, 2018
Towako Transmyometrial Embryo Transfer Set
K173431
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 197d
Cleared Apr 13, 2018
Pivet and Soft-Pass Embryo Transfer Catheter Sets
K173103
Cook Incorporated
Obstetrics & Gynecology · 196d
Cleared Apr 11, 2018
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
K173686
Cook Incorporated
Obstetrics & Gynecology · 131d
Cleared Jan 10, 2018
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
K172051
Cook Incorporated
Obstetrics & Gynecology · 188d
Cleared Dec 21, 2017
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
K172321
Cook Incorporated
Obstetrics & Gynecology · 142d
Cleared Jul 14, 2017
Soules Intrauterine Insemination Catheter
K163318
Cook Incorporated
Obstetrics & Gynecology · 233d
Cleared Jul 13, 2017
Kitazato ET Catheters
K162878
Kitazato Corporation
Obstetrics & Gynecology · 272d
Cleared May 11, 2017
Kitazato IUI Catheter
K162667
Kitazato Corporation
Obstetrics & Gynecology · 227d
Cleared Mar 09, 2017
Transem and EchoGen Embryo Transfer Catheters
K161547
Origio A/S
Obstetrics & Gynecology · 279d
Cleared Jan 05, 2017
CrossBay IVF Embryo Transfer Catheter Set
K162064
Crossbay Medical, Inc.
Obstetrics & Gynecology · 163d
Cleared Nov 23, 2015
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
K143669
Medgyn Products, Inc.
Obstetrics & Gynecology · 334d
Cleared Feb 03, 2015
FERTILIGENT SLOW RELEASE IUI CATHETER KIT
K141666
Fertiligent, Ltd.
Obstetrics & Gynecology · 225d
Cleared Sep 11, 2013
KITAZATO IUI CATHETER
K131491
Kitazato Medical Co., Ltd.
Obstetrics & Gynecology · 111d
Cleared Nov 02, 2012
IUI CATHETERS
K112396
Kitazato Medical Co., Ltd.
Obstetrics & Gynecology · 441d

About Product Code MQF - Regulatory Context

510(k) Submission Activity

53 total 510(k) submissions under product code MQF since 1998, with 53 receiving FDA clearance (average review time: 148 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - MQF Product Code

Recent submissions under MQF have taken an average of 201 days to reach a decision - up from 146 days historically. Manufacturers should account for longer review timelines in current project planning.

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