510(k) · Cleared

Cleared

LensHooke X12 PRO Semen Analysis System

K242388510(k) TraditionalCleared May 9, 2025270-day reviewClass II21 CFR 864.5220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bonraybio Co., Ltd. · POV Semen Analysis Device

Cleared on May 9, 2025 as substantially equivalent to K202089 (Bonraybio Co., Ltd., 2020) after a 270-day review. Its family tree reaches back 3 generations to 2002.

Decided: May 9, 2025
Review: 270 days
Class: Class II
Product code: POV
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K021746 (2002). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK021746 Sqa V, Sperm Quality AnalyzerMedical Electronic Systems, LLC · 2002
2 generations backK180343 LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality…Bonraybio Co., Ltd. · 2018
1 generation backK202089 LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen…Bonraybio Co., Ltd. · 2020
This deviceK242388 LensHooke X12 PRO Semen Analysis SystemBonraybio Co., Ltd. · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K021746	Sqa V, Sperm Quality Analyzer	Medical Electronic Systems, LLC	2002	—
−2	K180343	LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer	Bonraybio Co., Ltd.	2018	—
−1	K202089	LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality…	Bonraybio Co., Ltd.	2020	—
0 (this device)	K242388	LensHooke X12 PRO Semen Analysis System	Bonraybio Co., Ltd.	2025	—

FIG. 1 — Lineage of K242388, 2002–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in POV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new POV device

#1 K252228 Seaman Pro/Seamanscore 11.4 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K202089	LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer Summary page 7 …12 PRO Semen Analysis System is substantially equivalent to： LensHooke X1 PRO Semen Quality Analyzer Device Company: Bonraybio Co., LTD. 510(k) Number: K202089 7 Comparison to Predicate Device: LensHooke X12 PRO LensH…	Bonraybio Co., Ltd.	2020	—

Also cleared against K202089: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K202089.

How does its category compare?

All POV devices

POV Semen Analysis Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · POV

3in 2025

2007high 3 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · POV

253in 2025

2007high 253 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · POV

2in 2025

2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · POV

1in 2020

2007high 1 (2020) · low 0 (2007)2025

MAUDE reports naming product code POV, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	1	—	0	0
2009	0	—	0	0
2010	1	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	2	—	0	0
2017	1	—	0	0
2018	1	—	0	0
2019	1	—	0	0
2020	1	—	0	1
2021	0	—	0	0
2022	0	—	0	0
2023	1	—	0	0
2024	1	—	0	0
2025	3	253	2	0
2026	1	—	0	—

What is it indicated for?

The LensHooke X12 PRO Semen Analysis System used with LensHooke Semen Test Slide is an optical device for human semen analysis which provides direct and calculated measurements for: (1) Sperm concentration (M/mL) (2) Total motility (PR+NP, %) • Progressive Motility (PR, %) (3) Sperm Morphology (normal forms, %) The LensHooke X12 PRO Semen Analysis System used with LensHooke R10 Plus Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) and LensHooke R11…

Read the full statement (140 words)

The LensHooke X12 PRO Semen Analysis System used with LensHooke Semen Test Slide is an optical device for human semen analysis which provides direct and calculated measurements for:

(1) Sperm concentration (M/mL)

(2) Total motility (PR+NP, %)

• Progressive Motility (PR, %)

(3) Sperm Morphology (normal forms, %)

The LensHooke X12 PRO Semen Analysis System used with LensHooke R10 Plus Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) and LensHooke R11 Plus Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR Assay) is an optical device for human semen analysis which provides direct measurement for:

(1) Sperm DNA Fragmentation Index (DFI, %)

The LensHooke X12 PRO Semen Analysis System 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 clinical laboratories to evaluate male fertility.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K242388 · printed Nov 6, 2026

Cite this page

510(k) Report. “K242388: LensHooke X12 PRO Semen Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242388

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026