FDA Product Code MQF: Catheter, Assisted Reproduction
Leading manufacturers include Cook Incorporated, Allwin Medical Devices, Inc. and William A. Cook Australia Pty. , Ltd..
53
Total
53
Cleared
148d
Avg days
1998
Since
Growing category -
3 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
199d
recently vs 145d historically
FDA 510(k) Cleared Catheter, Assisted Reproduction Devices (Product Code MQF)
53 devices
Cleared
Feb 12, 2026
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
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)
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)
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology
196d
Cleared
Sep 22, 2023
FemaSeed Intratubal Insemination
Femasys, Inc.
Obstetrics & Gynecology
101d
Cleared
Dec 16, 2022
Daylily Single Use Sterile Embryo Transfer Catheter
Shanghai Horizon Medical Technology Co., Ltd.
Obstetrics & Gynecology
346d
Cleared
Jul 01, 2020
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
Allwin Medical Devices, Inc.
Obstetrics & Gynecology
152d
Cleared
May 01, 2020
Kitazato ET Catheters
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)
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)
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
Cook Incorporated
Obstetrics & Gynecology
264d
Cleared
May 18, 2018
Towako Transmyometrial Embryo Transfer Set
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology
197d
Cleared
Apr 13, 2018
Pivet and Soft-Pass Embryo Transfer Catheter Sets
Cook Incorporated
Obstetrics & Gynecology
196d
Cleared
Apr 11, 2018
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
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
Cook Incorporated
Obstetrics & Gynecology
188d
Cleared
Dec 21, 2017
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
Cook Incorporated
Obstetrics & Gynecology
142d
Cleared
Jul 14, 2017
Soules Intrauterine Insemination Catheter
Cook Incorporated
Obstetrics & Gynecology
233d
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 increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - MQF Product Code
Recent submissions under MQF have taken an average of 199 days to reach a decision - up from 145 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 →