Cleared Traditional

K013501 - IUI, MODEL 4220

Also marketed or referenced as:
SMOOZE, MODEL 4225, L SEMINOR, MODEL 4502 A, B

K013501 is an FDA 510(k) clearance for IUI, manufactured by Gynetics Medical Products NV. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K013501 · Gynetics Medical Products NV · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
39d
Days
Class 2
Risk

K013501 is an FDA 510(k) clearance for the IUI, MODEL 4220. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Gynetics Medical Products NV (Irvine, US). The FDA issued a Cleared decision on November 30, 2001 after a review of 39 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gynetics Medical Products NV devices

FDA 510(k) Submission Details - K013501

510(k) Number K013501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date November 30, 2001
Days to Decision 39 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 160d · This submission: 39d
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 31
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K013501.
Soules Intrauterine Insemination Catheter
K163318 · Cook Incorporated · Jul 2017
IUI CATHETERS
K112396 · Kitazato Medical Co., Ltd. · Nov 2012
INTRAUTERINE INSEMINATION (IUI) CATHETER
K120154 · Catheter Research, Inc. · Mar 2012
EMBRYON GIFT TRANSFER CATHETERS/SETS
K000656 · Rocket Medical Plc · Mar 2000
EMBRYON TRANSFER CATHETERS/SETS
K994327 · Rocket Medical Plc · Feb 2000
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
K992307 · Fertility Technology Resources, Inc. · Sep 1999