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Geri Embryo Incubator and Geri Dish

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180304

by Genea Biomedx Pty Ltd

Identifiers

510(k) Number
K180304 FDA 510(k)
FDA Product Code
MQG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.6120 FDA 510(k)
Regulation Number
884.6120 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Geri Embryo Incubator and Geri Dish is an accessory for assisted reproduction, classified as a Class II medical device under regulation number 884.6120. It is designed to provide stable culture conditions for embryo development outside the uterus, integrating time-lapse imaging to monitor key developmental stages in an undisturbed, individually controlled environment.

The device is supplied as a benchtop, modular incubator system intended for use in assisted reproduction laboratories. It provides humidified, warm, and stable incubation from fertilisation through to Day 5 of embryo culture. Authorisations include FDA 510(k) clearance (K180304) with a special clearance type, and it is registered under multiple FEI and registration numbers as specified in the device data.

Frequently asked questions

What is the Geri Embryo Incubator and Geri Dish used for?

It is designed to provide stable culture conditions for embryo development outside the uterus, integrating time-lapse imaging to monitor key developmental stages in an undisturbed, individually controlled environment from fertilisation through to Day 5 of embryo culture.

How is the Geri Embryo Incubator and Geri Dish supplied and where is it intended for use?

The device is supplied as a benchtop, modular incubator system intended for use in assisted reproduction laboratories to maintain humidified, warm, and stable conditions for embryo culture.

What regulatory clearance does the Geri Embryo Incubator and Geri Dish have?

It has FDA 510(k) clearance (K180304) with a special clearance type and is classified as a Class II medical device under regulation number 884.6120.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Geri® Time-Lapse IVF Incubator | Benchtop Embryo Incubator, Genea Biomedx: IVF Technology, The Geri® Incubator | Learn How Genea Grows Your Embryos

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Genea Biomedx Pty Ltd
FDA Applicant
Genea Biomedx Pty, Ltd.

Sources (1)

  • FDA 510(k) K180304 24 fields · synced Sep 25, 2026