# K242684: Harioculture TL-16 Time-lapse Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Hua Yue Medical Technology Co., Ltd.
- Decided: May 22, 2025 after 258 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K040717 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173264: EmbryoScope+, Vitrolife A/S (2018) Summary page 5.

## Indications for use
Harioculture TL-16 Time-lapse Incubator consists of the following devices with the following indications for use: Time-lapse Incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) or mixed gas (CO2 and other gases) for the development of embryos at or near body temperature. Use of the Time-lapse Incubator is limited to five days (120 hr) covering the time from post insemination to day five of development. The Hariomed culture dish is intended for preparing, storing, and transferring human embryos. The Hariomed culture dish must be used together with the Time-lapse Incubator. The Harioculture-client software is intended for displaying, comparing, storing, and transferring images generated by the Time-lapse Incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The Harioculture-client software does not control any hardware components in the Time-lapse Incubator. The Harioculture-server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters. The Time-lapse Incubator, Harioculture-client software, and Harioculture-server software must be used together to export embryo images from the Time-lapse Incubator. The Harioculture-client software and Harioculture-server software must be used together to assist users to analyze the embryo images.

Source page: https://510kreport.com/device/K242684
Methodology: https://510kreport.com/methodology