Cleared Traditional

K131491 - KITAZATO IUI CATHETER

K131491 is an FDA 510(k) clearance for KITAZATO IUI CATHETER, manufactured by Kitazato Medical Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K131491 · Kitazato Medical Co., Ltd. · Obstetrics & Gynecology device
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Sep 2013
Decision
111d
Days
Class 2
Risk

K131491 is an FDA 510(k) clearance for the KITAZATO IUI CATHETER. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Kitazato Medical Co., Ltd. (Austin, US). The FDA issued a Cleared decision on September 11, 2013 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - 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 Medical Co., Ltd. devices

FDA 510(k) Submission Details - K131491

510(k) Number K131491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2013
Decision Date September 11, 2013
Days to Decision 111 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
49d faster than avg
Panel avg: 160d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQF Device Classification - Class 2, Special Controls

Product Code MQF Catheter, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6110
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 - MQF Catheter, Assisted Reproduction

All 27
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K131491.
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
K172051 · Cook Incorporated · Jan 2018
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
K172321 · Cook Incorporated · Dec 2017
Soules Intrauterine Insemination Catheter
K163318 · Cook Incorporated · Jul 2017
EMBRYON GIFT TRANSFER CATHETERS/SETS
K000656 · Rocket Medical Plc · Mar 2000
EMBRYON TRANSFER CATHETERS/SETS
K994327 · Rocket Medical Plc · Feb 2000
EMBRYO TRANSFER CATHETER CC GLIDER
K991266 · Intl., Inc. · Sep 1999