# K242830: LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Bonraybio Co., Ltd.
- Decided: May 30, 2025 after 253 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 9.

## Indications for use
For Over-the-Counter Setting: The LensHooke® X3 PRO SE Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: (1) Sperm concentration (M/mL) (2) Total motility (PR+NP, %) - Progressive motility (%) - Non-Progressive motility (%) - Immotility (%) (3) Sperm morphology (normal forms, %) (4) pH value The LensHooke® X3 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male’s fertility status. It is a self-testing diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. For Point-of-Care Professional Setting: The LensHooke® X3 PRO Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: (1) Sperm concentration (M/mL) (2) Total motility (PR+NP, %) - Progressive motility (%) - Non-Progressive motility (%) - Immotility (%) (3) Sperm morphology (normal forms, %) (4) pH value The LensHooke® X3 PRO Semen Quality Analyzer 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 healthcare professional setting to evaluate male fertility.

Source page: https://510kreport.com/device/K242830
Methodology: https://510kreport.com/methodology