Cleared Special

K202089 - LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer (FDA 510(k) Clearance)

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K202089 · Bonraybio Co., Ltd. · Hematology device
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Oct 2020
Decision
92d
Days
Class 2
Risk

K202089 is an FDA 510(k) clearance for the LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality An.... Classified as Semen Analysis Device (product code POV), Class II - Special Controls.

Submitted by Bonraybio Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on October 28, 2020 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bonraybio Co., Ltd. devices

Submission Details

510(k) Number K202089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2020
Decision Date October 28, 2020
Days to Decision 92 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 113d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code POV Semen Analysis Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
Definition Device Used To Evaluate One Or More Human Semen Parameters Including Semen Volume, Sperm Concentration, Total Sperm Number, Sperm Motility, Sperm Morphology, Sperm Vitality, White Blood Cell Concentration, And Ph.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - POV Semen Analysis Device

All 27
Devices cleared under the same product code (POV) and FDA review panel - the closest regulatory comparables to K202089.
Seaman Pro/Seaman
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SQA-iOw Sperm Quality Analyzer
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YO Home Sperm Test
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SQA-iO Sperm Quality Analyzer
K220828 · Medical Electronic Systems , Ltd. · Aug 2023