Cleared Traditional

K170498 - Gems Oocyte Retrieval Buffer ORB-20, ORB-50 (FDA 510(k) Clearance)

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

K170498 · Genea Biomedx Pty, Ltd. · Obstetrics & Gynecology device
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Sep 2017
Decision
223d
Days
Class 2
Risk

K170498 is an FDA 510(k) clearance for the Gems Oocyte Retrieval Buffer ORB-20, ORB-50. 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 September 28, 2017 after a review of 223 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

Submission Details

510(k) Number K170498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2017
Decision Date September 28, 2017
Days to Decision 223 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
63d slower than avg
Panel avg: 160d · This submission: 223d
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.

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