MQE · Class II · 21 CFR 884.6100

FDA Product Code MQE: Needle, Assisted Reproduction

Leading manufacturers include CooperSurgical, Inc., Zhejiang Horizon Medical Technology Co., Ltd. and Shenzhen Vitavitro Biotech Co., Ltd..

32
Total
32
Cleared
145d
Avg days
1999
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 266d recently vs 141d historically

FDA 510(k) Cleared Needle, Assisted Reproduction Devices (Product Code MQE)

32 devices
1–24 of 32
Cleared Nov 15, 2024
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
K240523
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 266d
Cleared Feb 22, 2024
Lotus Single Lumen Ovum Aspiration Needle
K232163
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)
K190590
Allwin Medical Devices, Inc.
Obstetrics & Gynecology · 263d
Cleared Jun 12, 2019
Wallace Dual Lumen Oocyte Recovery System
K191291
CooperSurgical, Inc.
Obstetrics & Gynecology · 29d
Cleared May 10, 2019
Wallace Dual Lumen Oocyte Recovery System
K182959
CooperSurgical, Inc.
Obstetrics & Gynecology · 197d
Cleared Jan 12, 2018
Single Lumen Ovum Aspiration Needles
K171625
Willian A. Cook Australia Pty, Ltd.
Obstetrics & Gynecology · 224d

About Product Code MQE - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code MQE since 1999, with 32 receiving FDA clearance (average review time: 145 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - MQE Product Code

Recent submissions under MQE have taken an average of 266 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 →