# K962816: Sperm Preparation Media

- Pathway: 510(k) (Traditional)
- Applicant: Genx Intl., Inc.
- Decided: Nov 26, 1996 after 130 days
- Product code: MOL (Condom, Synthetic)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861188 (1987). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861188: Sperm Capacitation Medium, Irvine Scientific (1987) Summary page 1.

## Most influential descendants
- K991173: <Genx> Fertilization Media-HTF (1999), 0 descendants of its own

## Indications for use
Sperm Preparation Media is a culture media used to prepare sperm prior to Intrauterine Insemination (IUT) procedures. The preparation of sperm includes washing of the sperm and its separation from the semen. This products as indicated in the label is For In Vitro Use Only.

Source page: https://510kreport.com/device/K962816
Methodology: https://510kreport.com/methodology