# K073039: Spermcheck Vasectomy

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Jan 24, 2008 after 87 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: 4 generations back to K915229 (1994). 6 ancestors in all.
5 later devices descend from it; 1 cites 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)
- 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
- 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
- K172514: Trak Plus Male Fertility Testing System (2017), 0 descendants of its own

## Indications for use
SpermCheck® Vasectomy is a rapid qualitative test that detects low concentrations of sperm at or above 250,000 sperm/mL in human semen as an aid for vasectomized men. For in vitro, over the counter home use.

Source page: https://510kreport.com/device/K073039
Methodology: https://510kreport.com/methodology