# K011679: Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility

- Pathway: 510(k) (Traditional)
- Applicant: Embryotech Laboratories, Inc.
- Decided: Aug 15, 2001 after 77 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 K915229 (1994). 2 ancestors in all.
8 later devices descend from it; 3 cite 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)
- K983473: Fertilmarq Test Kit, Embryotech Laboratories, Inc. (1998) Summary page 1.

## Most influential descendants
- K041039: Fertell Male Fertility Test (2004), 7 descendants of its own
- K073039: Spermcheck Vasectomy (2008), 5 descendants of its own
- K100341: Spermcheck Fertility (2010), 4 descendants of its own
- K161493: YO Home Sperm Test (2016), 1 descendant of its own
- K153683: Trak Male Fertility Testing System (2016), 1 descendant of its own

## Indications for use
The FertiiMARQ™ Home Diagnostic Screening Test Kit for Male Infertility is a rapid test of your semen for sperm concentration. It will measure sperm as either above or below the cutoff of 20 million sperm cells per milliliter (mL). Two test results of less than 20 million cells/mL are an indicator of male infertility

Source page: https://510kreport.com/device/K011679
Methodology: https://510kreport.com/methodology