K242684 is an FDA 510(k) clearance for the Harioculture TL-16 Time-lapse Incubator, a Accessory, Assisted Reproduction (Class II — Special Controls, product code MQG), submitted by Hua Yue Medical Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 22, 2025, 258 days after receiving the submission on September 6, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6120.
| 510(k) Number | K242684 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 06, 2024 |
| Decision Date | May 22, 2025 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQG — Accessory, Assisted Reproduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6120 |