# K821186: Penetrak TM

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jun 25, 1982 after 59 days
- Product code: GKZ (Counter, Differential Cell)
- 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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
- K153683: Trak Male Fertility Testing System (2016), 1 descendant of its own

Source page: https://510kreport.com/device/K821186
Methodology: https://510kreport.com/methodology