Class Class II
LensHooke X12 PRO Semen Analysis System (K242388)
Description
LensHooke X12 PRO Semen Analysis System by Bonraybio Co., Ltd., an FDA 510(k) cleared hematology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242388
Clearance Date2025-05-09
Clearance TypeTraditional
Product CodePOV
Regulation Number864.5220
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242388
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. LensHooke X12 PRO Semen Analysis System (K242388) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO S... | Bonraybio Co., Ltd. | 2020 |
Trace the full predicate network for K242388
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.