Class Class II
Harioculture TL-16 Time-lapse Incubator (K242684)
Description
Harioculture TL-16 Time-lapse Incubator by Hua Yue Medical Technology Co., Ltd., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242684
Clearance Date2025-05-22
Clearance TypeTraditional
Product CodeMQG
Regulation Number884.6120
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242684
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Harioculture TL-16 Time-lapse Incubator (K242684) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173264 | EmbryoScope+ | Vitrolife A/S | 2018 |
Trace the full predicate network for K242684
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.