Hematology · 510(k) · 2026
Seaman Pro/Seaman
Checkcells, Inc.. Cleared by FDA on 9 April 2026 under submission K252228, product code POV (semen analysis device). What FDA's record says, in FDA's words.
Device record · K252228
- Device. Seaman Pro/SeamanDEVICE
- Company. Checkcells, Inc.COMPANY
- Decision. 9 April 2026, 510(k), substantially equivalent (traditional review); received 16 July 2025DECISION
- Panel. HematologyPANEL
- Product code. POV, Semen Analysis DeviceCODE
- Regulation. 21 CFR 864.5220, Class IIREG
- Source. FDA database entry · decision document (25 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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:
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
- Mentionsprescription use
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code POV. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
17 September 2020 · Malfunction · HALOTECH G2 KIT · HALOTECH, SRL. / HALOTECH DNA SL · report MW5096746
INCORRECT FERTILITY TMT; NOT AN INCIDENT BUT A VIOLATION: (B)(4), IS THE IMPORTER OF THE HALOTECH LINE OF SPERM TESTING KITS AND STAINS WHICH ARE WIDELY DISTRIBUTED IN THE US WITH MARKETING CLAIMS REGARDING DNA FRAGMENTATION THAT HAVE NEVER BEEN VALIDATED IN HUMAN CLINICAL TRIALS AND ARE NOT REVIEWED BY THE FDA AS A DIAGNOSTIC TEST. THE SAFETY AND EFFICACY AS WELL AS THERMAL STABILITY OF THE TESTS ARE UNKNOWN, YET THESE TESTS ARE MARKETED WIDELY TO THE IVF AND ART COMMUNITIES OF HEALTHCARE […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code POV, in Hematology, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.