MQH · Class II · 21 CFR 884.6130

FDA Product Code MQH: Microtools, Assisted Reproduction (pipettes)

Leading manufacturers include Research Instruments , Ltd., Cook Incorporated and Humagen Fertility Diagnostics, Inc..

26
Total
26
Cleared
153d
Avg days
1999
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 105d recently vs 155d historically

FDA 510(k) Cleared Microtools, Assisted Reproduction (pipettes) Devices (Product Code MQH)

26 devices
1–24 of 26
Cleared Jul 03, 2025
Denudation Pipettes
K250838
Guangzhou Pinzhi Medical Device Co., Ltd.
Obstetrics & Gynecology · 105d
Cleared Jan 28, 2020
V-DENUPET
K192146
Vitromed GmbH
Obstetrics & Gynecology · 173d
Cleared Jan 23, 2017
EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip
K161275
Research Instruments Limited
Obstetrics & Gynecology · 262d
Cleared Apr 11, 2016
LifeGlobal Micro Tips
K152581
Life Global Group, LLC
Obstetrics & Gynecology · 214d
Cleared Jan 08, 2016
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
K151018
Cook Incorporated
Obstetrics & Gynecology · 267d
Cleared Dec 18, 2015
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
K150748
Cook Incorporated
Obstetrics & Gynecology · 270d
Cleared May 16, 2014
BIOPSY PIPETTES
K133257
Research Instruments , Ltd.
Obstetrics & Gynecology · 205d
Cleared Apr 19, 2011
INJECTION PIPETTE
K102480
Jieying Laboratory, Inc.
Obstetrics & Gynecology · 232d
Cleared Apr 30, 2010
BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES
K092554
Sunlight Medical, Inc.
Obstetrics & Gynecology · 253d
Cleared May 19, 2008
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES
K072600
Sunlight Medical, Inc.
Obstetrics & Gynecology · 248d
Cleared Sep 29, 2004
THE STRIPPER PGD
K041435
Mid-Atlantic Diagnostics, Inc.
Obstetrics & Gynecology · 124d
Cleared Aug 09, 2004
CRYOTIP
K041562
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 60d
Cleared Jan 16, 2004
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
K033903
Cook Urological, Inc.
Obstetrics & Gynecology · 30d
Cleared Jan 16, 2004
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
K033904
Cook Urological, Inc.
Obstetrics & Gynecology · 30d
Cleared Feb 11, 2002
BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B
K012811
Humagen Fertility Diagnostics, Inc.
Obstetrics & Gynecology · 173d
Cleared Aug 18, 2000
HUNTER SCIENTIFIC INJECTION PIPETTES
K001615
Hunter Scientific Limited
Obstetrics & Gynecology · 85d
Cleared May 16, 2000
THE STRIPPER
K993699
Mid-Atlantic Diagnostics, Inc.
Obstetrics & Gynecology · 196d
Cleared Sep 13, 1999
ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M
K991388
Pacific Andrology, Inc.
Obstetrics & Gynecology · 145d
Cleared Aug 05, 1999
ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET
K991261
Research Instruments , Ltd.
Obstetrics & Gynecology · 114d
Cleared Jul 19, 1999
MICROTOOLS
K991104
Conception Technology, Inc.
Obstetrics & Gynecology · 109d
Cleared Jul 19, 1999
SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES
K991700
Swemed Lab International AB
Obstetrics & Gynecology · 62d
Cleared Jul 14, 1999
INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M
K990847
Humagen Fertility Diagnostics, Inc.
Obstetrics & Gynecology · 121d
Cleared Jun 08, 1999
PRODIMED MICROINJECTION PIPETTES
K983713
Prodimed
Obstetrics & Gynecology · 230d
Cleared Feb 05, 1999
INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
K983596
Cook Ob/Gyn
Obstetrics & Gynecology · 115d

About Product Code MQH - Regulatory Context

510(k) Submission Activity

26 total 510(k) submissions under product code MQH since 1999, with 26 receiving FDA clearance (average review time: 153 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MQH Product Code

Recent submissions under MQH have taken an average of 105 days to reach a decision - down from 155 days historically, suggesting improved FDA processing for this classification.

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