FDA 510(k)

LensHooke X12 PRO Semen Analysis System

K-Number: K242388 · 2025-05-09

Decision Date2025-05-09

Product CodePOV

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

LensHooke X12 PRO Semen Analysis System is a medical device manufactured by Bonraybio Co., Ltd.. It received FDA 510(k) clearance on 2025-05-09 under approval number K242388. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LensHooke X12 PRO Semen Analysis System?

LensHooke X12 PRO Semen Analysis System is a medical device that received FDA 510(k) clearance on 2025-05-09. It is manufactured by Bonraybio Co., Ltd.. The 510(k) number is K242388.

When was LensHooke X12 PRO Semen Analysis System approved by the FDA?

LensHooke X12 PRO Semen Analysis System received FDA 510(k) clearance on 2025-05-09, under approval number K242388.

What company makes LensHooke X12 PRO Semen Analysis System?

LensHooke X12 PRO Semen Analysis System is manufactured by Bonraybio Co., Ltd..

What is the FDA product code for LensHooke X12 PRO Semen Analysis System?

The FDA product code for LensHooke X12 PRO Semen Analysis System is POV.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Bonraybio Co., Ltd.

K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer K221810LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer

Related Devices (Code: POV)

K161493YO Home Sperm TestMedical Electronic Systems , Ltd. K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. K172514Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc. K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerBonraybio Co., Ltd. K183602SwimCount Sperm Quality TestMotilitycount Aps K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.