Hua Yue Medical Technology Co., Ltd. · Class II · Cleared May 22, 2025
| K-number | K242684 |
| Device name | Harioculture TL-16 Time-lapse Incubator |
| Applicant | Hua Yue Medical Technology Co., Ltd. |
| Product code | MQG |
| Device class | Class II |
| Decision date | May 22, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 884.6120 |
The Harioculture TL-16 Time-lapse Incubator is a benchtop embryo incubator with integrated microscopy for assisted reproductive technology. It provides controlled temperature and gas (CO₂ and O₂) environments for embryo culture and monitoring over five days post-insemination. The system includes the incubator hardware, Hariomed culture dishes, and client/server software for image display, annotation, and embryo selection modeling.
The subject device differs from the predicate (EmbryoScope+) in several specifications: 16-dish capacity versus 15, 20× magnification versus 16×, 1920×1200 pixel camera versus 2048×1088, supports both self-mixed and pre-mixed gas modes (predicate uses only individual gases), lower light dosage (52 J/m² versus 65.2 J/m²), and improved gas/temperature recovery times. Temperature accuracy is ±0.1°C versus ±0.2°C, and culture well volume is 2 μL versus 1.5 μL.
IEC 60601-1:2005/AMD2:2020 (electrical safety), IEC 60601-1-2:2014+A1:2020 and IEC TS 60601-4-2:2024 (EMC), ISO 11137-2:2013+A1:2022 (sterilization validation), ASTM D4169-23 (transportation simulation), ASTM F1980:2021 (shelf-life/accelerated aging), ASTM F2096-11 and F88/F88M-21 (package integrity), USP <85> (endotoxin), and FDA 2023 guidance on device software and cybersecurity.
The subject and predicate devices share the same intended use: time-lapse imaging and monitoring of embryos in assisted reproduction over five days. Although technological specifications differ (magnification, pixel count, gas control options, capacity), the differences do not raise questions of safety or effectiveness because both devices maintain equivalent temperature/gas control precision, achieve the same embryo culture outcomes (≥80% blastocyst development), and employ identical time-lapse imaging methodology with Hoffman modulation contrast microscopy. The subject device's improved specifications (faster recovery times, lower light exposure, tighter accuracy tolerances) and additional gas control flexibility do not present new risks.
View the full FDA submission: accessdata.fda.gov