Cleared Traditional

K112396 - IUI CATHETERS

K112396 is an FDA 510(k) clearance for IUI CATHETERS, 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 441-day FDA review.

K112396 · 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
441d
Days
Class 2
Risk

K112396 is an FDA 510(k) clearance for the IUI CATHETERS. 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 November 2, 2012 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - 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: 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 - K112396

510(k) Number K112396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2011
Decision Date November 02, 2012
Days to Decision 441 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
280d slower than avg
Panel avg: 161d · This submission: 441d
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 52
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K112396.
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
K143669 · Medgyn Products, Inc. · Nov 2015
FERTILIGENT SLOW RELEASE IUI CATHETER KIT
K141666 · Fertiligent, Ltd. · Feb 2015
KITAZATO IUI CATHETER
K131491 · Kitazato Medical Co., Ltd. · Sep 2013
INTRAUTERINE INSEMINATION (IUI) CATHETER
K120154 · Catheter Research, Inc. · Mar 2012
INTRAUTERINE INSEMINATION (IUI) CATHETER
K092579 · Fertiligent, Ltd. · Apr 2010
CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007
K053208 · Swemed Lab International AB · Jan 2006