# K080446: Rapidvit and Rapidwarm Cleave

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Nov 26, 2008 after 281 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 K060168 (2006). 1 ancestor in all.
21 later devices descend from it; 3 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)
- K060168: Vitrification Freeze Kit, Vitrification Thaw Kit, Irvine Scientific Sales Co., Inc. (2006) Summary page 1.

## 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

## Indications for use
RapidVit Tm Cleave is indicated for vitrification of day 3 cleavage stage embryos RapidWarm TM Cleave is indicated for warming of vitrified day 3 cleavage stage embryos RapidVit TM Cleavage and RapidWarm Cleavage are restricted to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K080446
Methodology: https://510kreport.com/methodology