# K153683: Trak Male Fertility Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Diagnostics, Inc.
- Decided: May 16, 2016 after 146 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). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 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.

## Most influential descendants
- K172514: Trak Plus Male Fertility Testing System (2017), 0 descendants of its own

## Indications for use
The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. Sperm concentration is only one factor that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use.

Source page: https://510kreport.com/device/K153683
Methodology: https://510kreport.com/methodology