# K100341: Spermcheck Fertility

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: May 4, 2010 after 88 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: 5 generations back to K915229 (1994). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073039: Spermcheck Vasectomy, Princeton BioMeditech Corp. (2008) Summary page 1.
- K041039: Fertell Male Fertility Test, Genosis, Ltd. (2004) Summary page 1.
- K011679: Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility, Embryotech Laboratories, Inc. (2001) Summary page 1.
- (no number) Hemacytometer: named in the summary without a submission number

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

## Indications for use
SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man’s fertility status. For in vitro, over the counter home use.

Source page: https://510kreport.com/device/K100341
Methodology: https://510kreport.com/methodology