# K041039: Fertell Male Fertility Test

- Pathway: 510(k) (Traditional)
- Applicant: Genosis, Ltd.
- Decided: Jul 20, 2004 after 89 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: 3 generations back to K915229 (1994). 5 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821186: Penetrak TM, Syva Co. (1982) Summary page 1.
- K011679: Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility, Embryotech Laboratories, Inc. (2001) Summary page 1.
- K920719: Ivos Analyzer, Hamilton Thorne Research (1992). Our OCR of the scanned summary read K920179, FDA’s number for Zippie P500 (Sunrise Medical Quickie Designs, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Hamilton Thorne IVOS”.
- K915229: Semen Analysis Kit, Humagen Fertility Diagnostics, Inc. (1994) Summary page 1.
- (no number) Sperm migration test (modified Kremer test): named in the summary without a submission number

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

## Indications for use
The Fertell Male Fertility Test is intended to measure motile sperm in semen as an adjunctive screen of male fertility for over-the-counter (OTC) home use.

Source page: https://510kreport.com/device/K041039
Methodology: https://510kreport.com/methodology