Cleared Traditional

K162409 - Gems Vitrification Set

K162409 is an FDA 510(k) clearance for Gems Vitrification Set, manufactured by Genea Biomedx Pty, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K162409 · Genea Biomedx Pty, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
268d
Days
Class 2
Risk

K162409 is an FDA 510(k) clearance for the Gems Vitrification Set, Gems Warming Set. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Genea Biomedx Pty, Ltd. (Sydney, AU). The FDA issued a Cleared decision on May 24, 2017 after a review of 268 days - an extended review cycle.

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 Genea Biomedx Pty, Ltd. devices

FDA 510(k) Submission Details - K162409

510(k) Number K162409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2016
Decision Date May 24, 2017
Days to Decision 268 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
108d slower than avg
Panel avg: 160d · This submission: 268d
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
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