# K101003: Rapidvit Blast, Rapidwarm Blast

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Dec 10, 2010 after 242 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: 2 generations back to K060168 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080446: Rapidvit and Rapidwarm Cleave, Vitrolife Sweden AB (2008) Summary page 1.
- K060168: Vitrification Freeze Kit, Vitrification Thaw Kit, Irvine Scientific Sales Co., Inc. (2006) Summary page 1.

## Most influential descendants
- K240605: Ultra RapidWarm™ Blast (2024), 0 descendants of its own

## Indications for use
RapidVit Tm Blast is indicated for vitrification of human blastocyst stage embryos RapidWarm Tm Blast is indicated for warming of vitrified human blastocyst stage embryos

Source page: https://510kreport.com/device/K101003
Methodology: https://510kreport.com/methodology