Cleared Traditional

K102480 - INJECTION PIPETTE

Also marketed or referenced as:
HOLDING PIPETTE BIOPSY PIPETTE DENUDING PIPETTE PARTIAL ZONA DISSECTION (PZD) PIPETTE ASSISTED HA

K102480 is an FDA 510(k) clearance for INJECTION PIPETTE, manufactured by Jieying Laboratory, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQH cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K102480 · Jieying Laboratory, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
232d
Days
Class 2
Risk

K102480 is an FDA 510(k) clearance for the INJECTION PIPETTE. Classified as Microtools, Assisted Reproduction (pipettes) (product code MQH), Class II - Special Controls.

Submitted by Jieying Laboratory, Inc. (Irvine, US). The FDA issued a Cleared decision on April 19, 2011 after a review of 232 days - an extended review cycle.

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 Jieying Laboratory, Inc. devices

FDA 510(k) Submission Details - K102480

510(k) Number K102480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2010
Decision Date April 19, 2011
Days to Decision 232 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 160d · This submission: 232d
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 8
Devices cleared under the same product code (MQH) and FDA review panel - the closest regulatory comparables to K102480.
V-DENUPET
K192146 · Vitromed GmbH · Jan 2020
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
K151018 · Cook Incorporated · Jan 2016
Flexipet Denuding Pipette, Flexipet Manipulation Pipette
K150748 · Cook Incorporated · Dec 2015
CRYOTIP
K041562 · Irvine Scientific Sales Co., Inc. · Aug 2004
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
K033903 · Cook Urological, Inc. · Jan 2004
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
K033904 · Cook Urological, Inc. · Jan 2004