# K983473: Fertilmarq Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Embryotech Laboratories, Inc.
- Decided: Dec 17, 1998 after 76 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: 1 generation back to K915229 (1994). 1 ancestor in all.
9 later devices descend 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)
- K915229: Semen Analysis Kit, Humagen Fertility Diagnostics, Inc. (1994) Summary page 1.

## Most influential descendants
- K011679: Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility (2001), 8 descendants of its own
- 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

## Indications for use
The FertilMARQ™ Test Kit is a semi-quantitative test for the rapid analysis of sperm concentration to aid in the determination of male infertility.

Source page: https://510kreport.com/device/K983473
Methodology: https://510kreport.com/methodology