Cleared Traditional

K180188 - Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (FDA 510(k) Clearance)

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

K180188 · Genea Biomedx Pty, Ltd. · Obstetrics & Gynecology device
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Jun 2018
Decision
135d
Days
Class 2
Risk

K180188 is an FDA 510(k) clearance for the Geri Embryo Incubator with Geri Connect and Geri Assess Software, 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 June 7, 2018 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - 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 K180188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2018
Decision Date June 07, 2018
Days to Decision 135 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
25d faster than avg
Panel avg: 160d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K180188.
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