# K242388: LensHooke X12 PRO Semen Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Bonraybio Co., Ltd.
- Decided: May 9, 2025 after 270 days
- Product code: POV (Semen Analysis Device)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K021746 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202089: LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer, Bonraybio Co., Ltd. (2020) Summary page 7.

## Indications for use
The LensHooke X12 PRO Semen Analysis System used with LensHooke Semen Test Slide is an optical device for human semen analysis which provides direct and calculated measurements for: (1) Sperm concentration (M/mL) (2) Total motility (PR+NP, %) • Progressive Motility (PR, %) (3) Sperm Morphology (normal forms, %) The LensHooke X12 PRO Semen Analysis System used with LensHooke R10 Plus Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) and LensHooke R11 Plus Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR Assay) is an optical device for human semen analysis which provides direct measurement for: (1) Sperm DNA Fragmentation Index (DFI, %) The LensHooke X12 PRO Semen Analysis System does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in clinical laboratories to evaluate male fertility.

Source page: https://510kreport.com/device/K242388
Methodology: https://510kreport.com/methodology