Cleared Traditional

K162881 - Kitazato OPU Needles

K162881 is an FDA 510(k) clearance for Kitazato OPU Needles, manufactured by Kitazato Corporation. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K162881 · Kitazato Corporation · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
270d
Days
Class 2
Risk

K162881 is an FDA 510(k) clearance for the Kitazato OPU Needles. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Kitazato Corporation (Tokyo, JP). The FDA issued a Cleared decision on July 11, 2017 after a review of 270 days - an extended review cycle.

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: 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 Kitazato Corporation devices

FDA 510(k) Submission Details - K162881

510(k) Number K162881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2016
Decision Date July 11, 2017
Days to Decision 270 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
109d slower than avg
Panel avg: 161d · This submission: 270d
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 Consultant

Emergo Global Consulting, LLC
Audrey Swearingen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K162881.
Single Lumen Ovum Aspiration Needles
K171625 · Willian A. Cook Australia Pty, Ltd. · Jan 2018
Double Lumen Ovum Aspiration Needles
K171611 · William A. Cook Australia Pty. , Ltd. · Dec 2017
Follicle Aspiration Set, Reduced Single Lumen
K172050 · Vitrolife Sweden AB · Nov 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
KITAZATO OPU NEEDLE
K112462 · Kitazato Medical Co., Ltd. · Nov 2012