# K240605: Ultra RapidWarm™ Blast

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Aug 7, 2024 after 156 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: 3 generations back to K060168 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101003: Rapidvit Blast, Rapidwarm Blast, Vitrolife Sweden AB (2010) Summary page 5.

## Indications for use
Ultra RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos.

Source page: https://510kreport.com/device/K240605
Methodology: https://510kreport.com/methodology