510(k) · Cleared
ClearedSeaman Pro/Seaman
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Checkcells, Inc. · POV Semen Analysis Device
Cleared on Apr 9, 2026 as substantially equivalent to K180343 (Bonraybio Co., Ltd., 2018) after a 267-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Apr 9, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- POV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021746 (2002). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K241628 YO Home Sperm Testscore 10.2 · 7 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 |
|---|---|---|---|
| * | K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerSummary page 8…© 2026 CheckCells, Inc. SEAPRO Seaman PRO 510(k) Summary Version: 8.4 Status: Published 510(k) Number: K180343 Predicate Device Name: LensHooke X1 PRO Semen Quality Analyzer Manufacturer: Bonraybio Co., Ltd. 4. Device Descr… | 2018 |
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 24 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K180343.
How does its category compare?
All POV devicesPOV Semen Analysis Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
The Seaman PRO Analyzer is an automated, point-of-care, in vitro use-only medical device for semen analysis performed by healthcare professionals. The desktop unit consists of a light source, optical elements, and an image sensor connected to a PC, which records a video of the semen sample and sends it to the cloud compute unit. The cloud compute unit runs software containing algorithms for assessing semen parameters. The product is a software-based…
Read the full statement (206 words)
The Seaman PRO Analyzer is an automated, point-of-care, in vitro use-only medical device for semen analysis performed by healthcare professionals. The desktop unit consists of a light source, optical elements, and an image sensor connected to a PC, which records a video of the semen sample and sends it to the cloud compute unit. The cloud compute unit runs software containing algorithms for assessing semen parameters. The product is a software-based medical device powered by ML that enables the user to further assess semen parameters, including concentration, motility, pH, morphology, and vitality. The product is intended for adult male patients to assess sperm quality. The product is not intended to process any of the PHI/PII.
Seaman PRO for prescription use only.
Seaman PRO used with Imaging Hardware 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, %)
3. Progressive motility (%)
4. pH value
5. Sperm morphology (normal forms, %)
6. Vitality (%)
The Seaman PRO device does not provide a comprehensive evaluation of a male's fertility status. Instead, it analyzes semen parameters which can be used by healthcare professionals as part of a broader assessment of male fertility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252228: Seaman Pro/Seaman.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252228
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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