# K241628: YO Home Sperm Test

- Pathway: 510(k) (Traditional)
- Applicant: Medical Electronic Systems, Ltd.
- Decided: Nov 29, 2024 after 176 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: 7 generations back to K915229 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161493: YO Home Sperm Test, Medical Electronic Systems, Ltd. (2016) Summary page 5.
- K021746: Sqa V, Sperm Quality Analyzer, Medical Electronic Systems, LLC (2002) Summary page 5.

## Indications for use
The YO Home Sperm Test (YO 3.0) is a smartphone-based test for semen analysis performed by lay users. The parameters reported by the YO Home Sperm Test (YO 3.0) are: 1. Total Sperm Concentration / Sperm Concentration, M/mL 2. Total Motile / Motility (PR + Non Progressive [NP]), % 3. Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %) 4. Motile Sperm Concentration (MSC), M/mL 5. Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapidly and Slowly Motile Sperm Concentration, M/mL) The YO Home Sperm Test (YO 3.0) does not provide a comprehensive evaluation of a male’s fertility status and is intended for in vitro, over the counter only.

Source page: https://510kreport.com/device/K241628
Methodology: https://510kreport.com/methodology