Cleared Traditional

K053494 - OIL FOR TISSUE CULTURE

K053494 is an FDA 510(k) clearance for OIL FOR TISSUE CULTURE, manufactured by Fertipro NV. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K053494 · Fertipro NV · Obstetrics & Gynecology device
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Mar 2006
Decision
98d
Days
Class 2
Risk

K053494 is an FDA 510(k) clearance for the OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Fertipro NV (Irvine, US). The FDA issued a Cleared decision on March 23, 2006 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - 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 Fertipro NV devices

FDA 510(k) Submission Details - K053494

510(k) Number K053494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2005
Decision Date March 23, 2006
Days to Decision 98 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 160d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQL Device Classification - Class 2, Special Controls

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
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 - MQL Media, Reproductive

All 168
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K053494.
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VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
K060168 · Irvine Scientific Sales Co., Inc. · Apr 2006
ICSI-100
K043116 · Vitrolife Sweden AB · Jan 2005
MEDICULT IVM SYSTEM
K041284 · Medicult A/S · Nov 2004
MEDIA CULTURE SYSTEM
K040530 · Intl., Inc. · Jun 2004