FDA Product Code MQE: Needle, Assisted Reproduction
Leading manufacturers include
33
Total
33
Cleared
149d
Avg days
1999
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
265d
recently vs 141d historically
FDA 510(k) Cleared Needle, Assisted Reproduction Devices (Product Code MQE)
33 devices
Cleared
Jun 15, 2026
Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle
Gimbo Medical Technology Shenzhen Co., Ltd.
Obstetrics & Gynecology
263d
Cleared
Nov 15, 2024
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology
266d
Cleared
Feb 22, 2024
Lotus Single Lumen Ovum Aspiration Needle
Zhejiang Horizon Medical Technology Co., Ltd.
Obstetrics & Gynecology
216d
Cleared
Nov 25, 2019
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
Allwin Medical Devices, Inc.
Obstetrics & Gynecology
263d
Cleared
Jun 12, 2019
Wallace Dual Lumen Oocyte Recovery System
CooperSurgical, Inc.
Obstetrics & Gynecology
29d
Cleared
May 10, 2019
Wallace Dual Lumen Oocyte Recovery System
CooperSurgical, Inc.
Obstetrics & Gynecology
197d
Cleared
Jan 12, 2018
Single Lumen Ovum Aspiration Needles
Willian A. Cook Australia Pty, Ltd.
Obstetrics & Gynecology
224d
Cleared
Dec 15, 2017
Double Lumen Ovum Aspiration Needles
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology
197d
Cleared
Nov 21, 2017
Follicle Aspiration Set, Reduced Single Lumen
Vitrolife Sweden AB
Obstetrics & Gynecology
138d
Cleared
Jul 11, 2017
Kitazato OPU Needles
Kitazato Corporation
Obstetrics & Gynecology
270d
Cleared
Jun 14, 2017
Follicle Aspiration Set
Vitrolife Sweden AB
Obstetrics & Gynecology
331d
Cleared
Aug 07, 2014
OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology
76d
Cleared
Nov 26, 2012
KITAZATO OPU NEEDLE
Kitazato Medical Co., Ltd.
Obstetrics & Gynecology
458d
Cleared
Feb 06, 2009
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
Vitrolife Sweden AB
Obstetrics & Gynecology
142d
Cleared
Oct 07, 2005
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
Inntec, Inc.
Obstetrics & Gynecology
101d
Cleared
Aug 08, 2003
EMBRYON ULTRASOUND NEEDLE GUIDE
Rocket Medical Plc
Radiology
39d
Cleared
Jan 22, 2003
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
CooperSurgical, Inc.
Obstetrics & Gynecology
58d
Cleared
Apr 19, 2000
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
Rocket Medical Plc
Obstetrics & Gynecology
89d
Cleared
Mar 08, 2000
OOCYTE ASPIRATION NEEDLE
Casmed UK
Obstetrics & Gynecology
330d
Cleared
Mar 01, 2000
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
Cook Urological, Inc.
Obstetrics & Gynecology
63d
Cleared
Sep 13, 1999
OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
Lifetek Medical, Inc.
Obstetrics & Gynecology
66d
Cleared
Sep 09, 1999
Obstetrics & Gynecology
164d
Cleared
Sep 09, 1999
Obstetrics & Gynecology
149d
Cleared
Sep 09, 1999
Obstetrics & Gynecology
149d
About Product Code MQE - Regulatory Context
510(k) Submission Activity
33 total 510(k) submissions under product code MQE since 1999, with 33 receiving FDA clearance (average review time: 149 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - MQE Product Code
Recent submissions under MQE have taken an average of 265 days to reach a decision - up from 141 days historically. Manufacturers should account for longer review timelines in current project planning.
MQE devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →