Cleared Traditional

K990847 - INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M

K990847 is an FDA 510(k) clearance for INTRACYTOPLASMIC SPERM INJECTION MICROP..., manufactured by Humagen Fertility Diagnostics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQH cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K990847 · Humagen Fertility Diagnostics, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
121d
Days
Class 2
Risk

K990847 is an FDA 510(k) clearance for the INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPET.... Classified as Microtools, Assisted Reproduction (pipettes) (product code MQH), Class II - Special Controls.

Submitted by Humagen Fertility Diagnostics, Inc. (Charlottesville, US). The FDA issued a Cleared decision on July 14, 1999 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6130 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Humagen Fertility Diagnostics, Inc. devices

FDA 510(k) Submission Details - K990847

510(k) Number K990847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1999
Decision Date July 14, 1999
Days to Decision 121 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 160d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQH Device Classification - Class 2, Special Controls

Product Code MQH Microtools, Assisted Reproduction (pipettes)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MQH Microtools, Assisted Reproduction (pipettes)

All 14
Devices cleared under the same product code (MQH) and FDA review panel - the closest regulatory comparables to K990847.
ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET
K991261 · Research Instruments , Ltd. · Aug 1999
MICROTOOLS
K991104 · Conception Technology, Inc. · Jul 1999
SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES
K991700 · Swemed Lab International AB · Jul 1999
PRODIMED MICROINJECTION PIPETTES
K983713 · Prodimed · Jun 1999
INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
K983596 · Cook Ob/Gyn · Feb 1999