# K011157: Cook Ivf Cryopreservation Kit and the Cook Ivf Thaw Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: May 3, 2001 after 17 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.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093273: Vit Kit - Freeze and Thaw (2010), 17 descendants of its own
- K160006: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit (2016), 14 descendants of its own
- K171748: Vitrification Kit and Thawing Kit (2017), 7 descendants of its own
- K190152: Vit Kit- Freeze NX and Vit Kit- Warm NX (2019), 2 descendants of its own
- K251305: Ultra-Fast Vitri; Ultra-Fast Warm (2025), 1 descendant of its own

Source page: https://510kreport.com/device/K011157
Methodology: https://510kreport.com/methodology