# K000309: Blastocyst Freeze Medium, Blastocyst Thaw Medium

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Mar 13, 2000 after 41 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.
22 later devices descend from it; 2 cite it directly.
0 of 23 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
- K032154: G-Freezekit Blast (2004), 20 descendants of its own
- K032155: G-Thawkit Blast (2004), 20 descendants of its own
- K073522: Vitrification Kit & Vitrification Warming Kit (2008), 19 descendants of its own
- 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

Source page: https://510kreport.com/device/K000309
Methodology: https://510kreport.com/methodology