Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180188 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 is a device designed for assisted reproduction, specifically for the culture and maintenance of embryos. It provides a controlled environment to support embryo development, incorporating integrated software modules—Geri Connect and Geri Assess—to monitor and assess embryo conditions in real time.
This system is supplied as a reusable incubator paired with single-use Geri Dishes, ensuring sterility and compliance with assisted reproduction protocols. Authorized under FDA 510(k) clearance and MDD, it operates within Class II medical device regulations and is intended for use in clinical embryology laboratories. Storage and handling follow manufacturer guidelines to maintain environmental integrity and software functionality.
Frequently asked questions
What is the primary purpose of the Geri Embryo Incubator, and how does it support embryo development?
The Geri Embryo Incubator is designed specifically for assisted reproduction to provide a controlled environment for the culture and maintenance of embryos. It ensures optimal conditions for embryo development by maintaining precise environmental parameters. The system includes integrated software modules—Geri Connect and Geri Assess—to continuously monitor and assess embryo conditions in real time, helping clinicians track progress and make informed decisions.
Are the Geri Dishes provided with the incubator single-use or reusable, and why does this matter?
The Geri Dishes supplied with the Geri Embryo Incubator are single-use, ensuring sterility and compliance with assisted reproduction protocols. This design choice prevents cross-contamination between different embryo cultures, reducing the risk of introducing pathogens or external variables that could compromise embryo viability or laboratory safety standards.
How is the incubator’s sterility maintained, and what storage or handling guidelines should be followed?
The Geri Embryo Incubator itself is reusable, but it is paired with single-use Geri Dishes to maintain sterility. To preserve environmental integrity and software functionality, storage and handling must follow the manufacturer’s guidelines, which likely include protecting the device from dust, moisture, and extreme temperatures, as well as ensuring proper calibration and maintenance of the incubator’s internal systems.
What software features are included with the Geri Embryo Incubator, and how do they benefit clinical workflow?
The system includes Geri Connect and Geri Assess software modules, which enable real-time monitoring and assessment of embryo conditions. Geri Connect likely facilitates data logging and remote connectivity, while Geri Assess provides analytical tools to evaluate embryo development metrics. These features streamline workflow by automating documentation and offering actionable insights for embryologists.
What regulatory pathways does the Geri Embryo Incubator follow, and which advisory committee oversees submissions?
The Geri Embryo Incubator is authorized under both FDA 510(k) clearance and the EU’s Medical Device Directive (MDD), placing it under Class II medical device regulations. Submissions for FDA clearance are reviewed by the Obstetrics/Gynecology (OB) Advisory Committee, which evaluates devices related to assisted reproduction, ensuring compliance with safety and performance standards before approval.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180188 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genea Biomedx Pty Ltd
- FDA Applicant
- Genea Biomedx Pty, Ltd.
Sources (2)
- FDA 510(k) K180188 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026