Cleared Traditional

K032208 - MONA LISA ASPIRATION NEEDLE

K032208 is an FDA 510(k) clearance for MONA LISA ASPIRATION NEEDLE, manufactured by Fertility Technology Resources, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K032208 · Fertility Technology Resources, Inc. · Obstetrics & Gynecology device
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Dec 2003
Decision
144d
Days
Class 2
Risk

K032208 is an FDA 510(k) clearance for the MONA LISA ASPIRATION NEEDLE. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Fertility Technology Resources, Inc. (Marietta, US). The FDA issued a Cleared decision on December 9, 2003 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6100 - 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.

View all Fertility Technology Resources, Inc. devices

FDA 510(k) Submission Details - K032208

510(k) Number K032208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2003
Decision Date December 09, 2003
Days to Decision 144 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
16d faster than avg
Panel avg: 160d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQE Device Classification - Class 2, Special Controls

Product Code MQE Needle, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6100
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 - MQE Needle, Assisted Reproduction

All 22
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K032208.
Follicle Aspiration Set, Reduced Single Lumen
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Follicle Aspiration Set
K161970 · Vitrolife Sweden AB · Jun 2017
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
K082727 · Vitrolife Sweden AB · Feb 2009
EMBRYON ULTRASOUND NEEDLE GUIDE
K032015 · Rocket Medical Plc · Aug 2003
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · CooperSurgical, Inc. · Jan 2003
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
K000205 · Rocket Medical Plc · Apr 2000