# K252228: Seaman Pro/Seaman

- Pathway: 510(k) (Traditional)
- Applicant: Checkcells, Inc.
- Decided: Apr 9, 2026 after 267 days
- Product code: POV (Semen Analysis Device)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021746 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180343: LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer, Bonraybio Co., Ltd. (2018) Summary page 8.

## Indications for use
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.

Source page: https://510kreport.com/device/K252228
Methodology: https://510kreport.com/methodology