Cleared Traditional

K161261 - Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

K161261 is an FDA 510(k) clearance for Gems Geri Medium, 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 373-day FDA review.

K161261 · Genea Biomedx Pty, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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

FDA 510(k) Submission Details - K161261

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 161d · This submission: 373d
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 Consultant

Donawa Lifescience Consulting Srl
Roger Gray

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQL Media, Reproductive

All 259
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K161261.
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Gems Vitrification Set, Gems Warming Set
K162409 · Genea Biomedx Pty, Ltd. · May 2017
SAGE Vitrification Kit and SAGE Vitrification Warming Kit
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Sydney IVF Culture Oil
K170257 · William A. Cook Australia Pty. , Ltd. · Feb 2017
Cryotop Vitrification Kit and Cryotop Thawing Kit
K160864 · Kitazato Biopharma Co;Ltd · Oct 2016