Cleared Traditional

K161261 - Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161261 · Genea Biomedx Pty, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
373d
Days
Class 2
Risk

K161261 is an FDA 510(k) clearance for the Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blast.... 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 12, 2017 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K161261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2016
Decision Date May 12, 2017
Days to Decision 373 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
213d slower than avg
Panel avg: 160d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 258
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K161261.
Ultra-Fast Warm
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Fast Warm - NX
K250445 · Fujifilm Irvine Scientific · Sep 2025
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]
K251637 · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Aug 2025
Ultra-Fast Vitri
K251305 · Kitazato Corporation · Aug 2025
FertiCult Flushing medium
K242640 · Fertipro NV · May 2025