# K991421: Freezing Medium - Test Yolk Buffer (Tyb) with Glycerol, Refrigeration Medium - Test Yolk Buffer 9TYB)

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Jul 2, 1999 after 70 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K192845: Sperm Freeze, Sperm Fridge (2020), 0 descendants of its own

## Indications for use
Refrigeration Medium — Test Yolk Buffer and Freezing Medium — Test Yolk Buffer with Glycerol are intended for use in assisted reproductive technology procedures that involve the manipulation and storage of semen samples prior to use in in vitro fertilization and other similar treatments. Refrigeration Medium — Test Yolk Buffer is specifically designed for to protect semen samples during refrigerated storage, while Freezing Medium — Test Yolk Buffer with Glycerol is intended to be used as a cryopreservative of semen samples.

Source page: https://510kreport.com/device/K991421
Methodology: https://510kreport.com/methodology