# K202089: LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer

- Pathway: 510(k) (Special)
- Applicant: Bonraybio Co., Ltd.
- Decided: Oct 28, 2020 after 92 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: 2 generations back to K021746 (2002). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180343: LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer, Bonraybio Co., Ltd. (2018) Summary page 8.

## Most influential descendants
- K242830: LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (2025), 0 descendants of its own
- K242388: LensHooke X12 PRO Semen Analysis System (2025), 0 descendants of its own

## Indications for use
The LensHooke X1 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 (10^6 per ml) (2) Total motility (PR+NP, %) - Progressive motility (%) - Non-Progressive motility (%) (3) Sperm morphology (normal forms, %) (4) pH value The LensHooke X1 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. The LensHooke X1 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: -Sperm concentration (10^6 per ml) -Total motility (PR+NP, %) -Sperm morphology (normal forms, %) -pH value The LensHooke X1 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male’s fertility status. It is a self-testing, in-vitro diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. The systems are intended for single person use only and should not be shared.

Source page: https://510kreport.com/device/K202089
Methodology: https://510kreport.com/methodology