# K061371: Sydney Ivf Sperm Cryopreservation Buffer

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Aug 17, 2006 after 92 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
- K160814: Sydney IVF Sperm Cryopreservation Buffer (2016), 0 descendants of its own

## Indications for use
Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.

Source page: https://510kreport.com/device/K061371
Methodology: https://510kreport.com/methodology