Cleared Traditional

K112462 - KITAZATO OPU NEEDLE

K112462 is an FDA 510(k) clearance for KITAZATO OPU NEEDLE, manufactured by Kitazato Medical Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 458-day FDA review.

K112462 · Kitazato Medical Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
458d
Days
Class 2
Risk

K112462 is an FDA 510(k) clearance for the KITAZATO OPU NEEDLE. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Kitazato Medical Co., Ltd. (Austin, US). The FDA issued a Cleared decision on November 26, 2012 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6100 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Kitazato Medical Co., Ltd. devices

FDA 510(k) Submission Details - K112462

510(k) Number K112462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2011
Decision Date November 26, 2012
Days to Decision 458 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
298d slower than avg
Panel avg: 160d · This submission: 458d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQE Device Classification - Class 2, Special Controls

Product Code MQE Needle, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6100
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 - MQE Needle, Assisted Reproduction

All 17
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K112462.
Single Lumen Ovum Aspiration Needles
K171625 · Willian A. Cook Australia Pty, Ltd. · Jan 2018
Follicle Aspiration Set, Reduced Single Lumen
K172050 · Vitrolife Sweden AB · Nov 2017
Follicle Aspiration Set
K161970 · Vitrolife Sweden AB · Jun 2017
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
K082727 · Vitrolife Sweden AB · Feb 2009
EMBRYON ULTRASOUND NEEDLE GUIDE
K032015 · Rocket Medical Plc · Aug 2003
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · CooperSurgical, Inc. · Jan 2003