510(k) · Cleared
ClearedLensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonraybio Co., Ltd. · POV Semen Analysis Device
Cleared on Nov 16, 2018 as substantially equivalent to K021746 (Medical Electronic Systems, LLC, 2002) after a 282-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it.
- Decided
- Nov 16, 2018
- Review
- 282 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021746 (2002). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK021746 Sqa V, Sperm Quality AnalyzerMedical Electronic Systems, LLC · 2002
- This deviceK180343 LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality…Bonraybio Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK202089 LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen…Bonraybio Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK252228 Seaman Pro/SeamanCheckcells, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK242830 LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen…Bonraybio Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK242388 LensHooke X12 PRO Semen Analysis SystemBonraybio Co., Ltd. · 2025
Most influential descendants
Showing 4 of 4 · See all- K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd. · 2020 · cites it directly2descendants
- K252228Seaman Pro/SeamanCheckcells, Inc. · 2026 · cites it directly0descendants
- K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd. · 2025 · 2 generations on0descendants
- K242388LensHooke X12 PRO Semen Analysis SystemBonraybio Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021746 | Sqa V, Sperm Quality Analyzer | Medical Electronic Systems, LLC | 2002 | — |
| 0 (this device) | 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 | — |
| +1 | K252228 | Seaman Pro/Seaman | Checkcells, Inc. | 2026 | — |
| +2 | K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality… | Bonraybio Co., Ltd. | 2025 | — |
| +2 | K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K021746 | Sqa V, Sperm Quality AnalyzerSummary page 7…y Analyzers are substantially equivalent to: SQA V, Sperm Quality Analyzer – Visual Device Company: Medical Electronic System, LLC 510(k) Number: k021746 Sec 8-3 7. Comparison to Predicate Devices:… | 2002 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All POV devicesPOV Semen Analysis Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · POV
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POV
253in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · POV
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · POV
1in 2020
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?
LensHooke X1 Semen Quality Analyzer for OTC use The LensHooke X1 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 Semen Quality Analyzer does not provide a comprehensive evaluation of a male’s fertility…
Read the full statement (208 words)
LensHooke X1 Semen Quality Analyzer for OTC use
The LensHooke X1 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 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.
LensHooke X1 PRO Semen Quality Analyzer for prescription 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180343: LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180343
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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