Cleared Special

K180304 - Geri Embryo Incubator and Geri Dish (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180304 · Genea Biomedx Pty, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
77d
Days
Class 2
Risk

K180304 is an FDA 510(k) clearance for the Geri Embryo Incubator and Geri Dish. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Genea Biomedx Pty, Ltd. (Sydney, AU). The FDA issued a Cleared decision on April 20, 2018 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Genea Biomedx Pty, Ltd. devices

Submission Details

510(k) Number K180304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2018
Decision Date April 20, 2018
Days to Decision 77 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 160d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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 - MQG Accessory, Assisted Reproduction

All 45
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K180304.
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