Harioculture TL-16 Time-lapse Incubator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242684 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 Harioculture TL-16 Time-lapse Incubator is an accessory for assisted reproduction designed to provide stable gas and temperature control for embryo culture. It features built-in time-lapse imaging to provide continuous records for embryologists, supporting both dry and humidified culture methods.
This device is supplied for use in clinical settings and has received FDA 510(k) clearance. It is designed with a 16-chamber capacity to facilitate individual embryo imaging and analysis.
Frequently asked questions
What is the primary function of the Harioculture TL-16?
The Harioculture TL-16 is an accessory for assisted reproduction designed to provide stable gas and temperature control for embryo culture. It includes built-in time-lapse imaging to provide continuous records for embryologists.
How many embryos can be processed at once in this incubator?
The device features a 16-chamber capacity. This design is intended to facilitate individual embryo imaging and analysis for each sample.
Does the incubator support different culture methods?
Yes, the Harioculture TL-16 is designed to support both dry and humidified culture methods, providing flexibility for clinical laboratory protocols.
What is the regulatory status of this device?
The Harioculture TL-16 Time-lapse Incubator has received FDA 510(k) clearance under K242684, confirming it has been reviewed and found substantially equivalent for its intended use in clinical settings.
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: Harioculture TL-16 - huayue-global.com, Harioculture TL-16 Time-lapse Incubator (K242684) — FDA 510 (k ..., Time-Lapse Incubator: TL-16 - huayue-global.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242684 | Class II | Active |
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Manufacturer
- Manufacturer
- Hua Yue Medical Technology Co., Ltd.
Sources (1)
- FDA 510(k) K242684 24 fields · synced Sep 21, 2026