# K915229: Semen Analysis Kit

- Pathway: 510(k) (Traditional)
- Applicant: Humagen Fertility Diagnostics, Inc.
- Decided: Aug 30, 1994 after 1,014 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
No predicates in its family tree.
10 later devices descend from it; 2 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K983473: Fertilmarq Test Kit (1998), 9 descendants of its own
- 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

Source page: https://510kreport.com/device/K915229
Methodology: https://510kreport.com/methodology