# K920719: Ivos Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Thorne Research
- Decided: Jun 29, 1992 after 132 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- 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; 3 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 lists a 510(k) statement for it but has not posted the file, 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/K920719
Methodology: https://510kreport.com/methodology