# K192845: Sperm Freeze, Sperm Fridge

- Pathway: 510(k) (Traditional)
- Applicant: Kitazato Corporation
- Decided: Aug 17, 2020 after 319 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 K991421 (1999). 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)
- K991421: Freezing Medium - Test Yolk Buffer (Tyb) with Glycerol, Refrigeration Medium - Test Yolk Buffer 9TYB), Irvine Scientific Sales Co., Inc. (1999) Summary page 4.

## Indications for use
Sperm Freeze is intended for the cryopreservation of human semen samples prior to use in assisted reproductive technology procedures. Sperm Fridge is intended to protect human semen samples during refrigerated storage prior to use in assisted reproductive technology procedures.

Source page: https://510kreport.com/device/K192845
Methodology: https://510kreport.com/methodology