# K161493: YO Home Sperm Test

- Pathway: 510(k) (Traditional)
- Applicant: Medical Electronic Systems, Ltd.
- Decided: Nov 8, 2016 after 160 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: 6 generations back to K915229 (1994). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100341: Spermcheck Fertility, Princeton BioMeditech Corp. (2010) Summary page 4.
- K021746: Sqa V, Sperm Quality Analyzer, Medical Electronic Systems, LLC (2002) Summary page 4.

## Most influential descendants
- K241628: YO Home Sperm Test (2024), 0 descendants of its own

## Indications for use
The YO™ Home Sperm Test is a smartphone based home test which provides a qualitative assessment of motile sperm concentration (MSC) in human semen. MSC is one aspect of a male semen examination. The YO™ Home Sperm Test does not provide a comprehensive- evaluation of a male's fertility status and is intended for over-the-counter, in vitro use only.

Source page: https://510kreport.com/device/K161493
Methodology: https://510kreport.com/methodology