# K113786: Spermfreeze Solution

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Oct 26, 2012 after 309 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- 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 K070689 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070689: LG Sperm Freezing, Genx Intl., Inc. (2007) Summary page 1.

## Indications for use
SpermFreeze Solution™ is indicated for cryopreservation of human sperm

Source page: https://510kreport.com/device/K113786
Methodology: https://510kreport.com/methodology