Cleared Traditional

K141666 - FERTILIGENT SLOW RELEASE IUI CATHETER KIT

K141666 is an FDA 510(k) clearance for FERTILIGENT SLOW RELEASE IUI CATHETER KIT, manufactured by Fertiligent, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K141666 · Fertiligent, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
225d
Days
Class 2
Risk

K141666 is an FDA 510(k) clearance for the FERTILIGENT SLOW RELEASE IUI CATHETER KIT. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Fertiligent, Ltd. (Indianapolis, US). The FDA issued a Cleared decision on February 3, 2015 after a review of 225 days - an extended review 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 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.

FDA 510(k) Submission Details - K141666

510(k) Number K141666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2014
Decision Date February 03, 2015
Days to Decision 225 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
64d slower than avg
Panel avg: 161d · This submission: 225d
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 K141666.
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CrossBay IVF Embryo Transfer Catheter Set
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MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
K143669 · Medgyn Products, Inc. · Nov 2015
KITAZATO IUI CATHETER
K131491 · Kitazato Medical Co., Ltd. · Sep 2013
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K112396 · Kitazato Medical Co., Ltd. · Nov 2012
INTRAUTERINE INSEMINATION (IUI) CATHETER
K120154 · Catheter Research, Inc. · Mar 2012