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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
297d slower than avg
Panel avg: 161d · 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 32
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K112462.
Kitazato OPU Needles
K162881 · Kitazato Corporation · Jul 2017
Follicle Aspiration Set
K161970 · Vitrolife Sweden AB · Jun 2017
OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
K141365 · William A. Cook Australia Pty. , Ltd. · Aug 2014
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
K082727 · Vitrolife Sweden AB · Feb 2009
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
K051742 · Inntec, Inc. · Oct 2005
MONA LISA ASPIRATION NEEDLE
K032208 · Fertility Technology Resources, Inc. · Dec 2003