# Bonraybio Co., Ltd.

- Location (FDA's records): Taichung, TW
- FDA decisions: 5 (2018–2025): 5 510(k) clearances
- Product codes: POV (4), MQK (1)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dxnow, Inc.: 1 (https://510kreport.com/company/dxnow)
- Medical Electronic Systems, Ltd.: 1 (https://510kreport.com/company/medical-electronic-systems)

## Firms that cite its devices most
- Checkcells, Inc.: 1 (https://510kreport.com/company/checkcells)

## Its most-cited devices
- K202089: LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer (2020), cited by 2
- K180343: LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer (2018), cited by 2

## Recent decisions
- K242830: LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (May 30, 2025)
- K242388: LensHooke X12 PRO Semen Analysis System (May 9, 2025)
- K221810: LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device (Oct 31, 2022)
- K202089: LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer (Oct 28, 2020)
- K180343: LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer (Nov 16, 2018)

Source page: https://510kreport.com/company/bonraybio