Cleared Traditional

K092579 - INTRAUTERINE INSEMINATION (IUI) CATHETER

K092579 is an FDA 510(k) clearance for INTRAUTERINE INSEMINATION (IUI) CATHETER, 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 228-day FDA review.

K092579 · Fertiligent, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
228d
Days
Class 2
Risk

K092579 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 Fertiligent, Ltd. (Indianapolis, US). The FDA issued a Cleared decision on April 2, 2010 after a review of 228 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 - K092579

510(k) Number K092579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2009
Decision Date April 02, 2010
Days to Decision 228 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
67d slower than avg
Panel avg: 161d · This submission: 228d
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 K092579.
KITAZATO IUI CATHETER
K131491 · Kitazato Medical Co., Ltd. · Sep 2013
IUI CATHETERS
K112396 · Kitazato Medical Co., Ltd. · Nov 2012
INTRAUTERINE INSEMINATION (IUI) CATHETER
K120154 · Catheter Research, Inc. · Mar 2012
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
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
K050521 · Inntec, Inc. · May 2005