Cleared Abbreviated

K120154 - INTRAUTERINE INSEMINATION (IUI) CATHETER

K120154 is an FDA 510(k) clearance for INTRAUTERINE INSEMINATION (IUI) CATHETER, manufactured by Catheter Research, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Abbreviated 510(k) pathway after a 63-day FDA review.

K120154 · Catheter Research, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
63d
Days
Class 2
Risk

K120154 is an FDA 510(k) clearance for the INTRAUTERINE INSEMINATION (IUI) CATHETER. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Catheter Research, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 21, 2012 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K120154

510(k) Number K120154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2012
Decision Date March 21, 2012
Days to Decision 63 days
Submission Type Abbreviated
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
98d faster than avg
Panel avg: 161d · This submission: 63d
Pathway characteristics
Standards-based clearance path.

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 K120154.
FERTILIGENT SLOW RELEASE IUI CATHETER KIT
K141666 · Fertiligent, Ltd. · Feb 2015
KITAZATO IUI CATHETER
K131491 · Kitazato Medical Co., Ltd. · Sep 2013
IUI CATHETERS
K112396 · Kitazato Medical Co., Ltd. · Nov 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
IUI CATHETER, MODEL 9057
K052059 · Inntec, Inc. · Nov 2005