# K140207: Rapid-I Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Dec 18, 2014 after 324 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- 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 K041562 (2004). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090832: Rapid-I, Vitrolife Sweden AB (2009) Summary page 5.

## Most influential descendants
- K181461: Rapid-i™ Kit (2019), 3 descendants of its own
- K200815: VitriGuard (2020), 2 descendants of its own
- K241341: cryo-GO Vitrification Device (2024), 0 descendants of its own
- K233177: Nest VT Vitrification Device (2024), 0 descendants of its own

## Indications for use
The Rapid-i™ Kit is a cryopreservation device designed to contain, vitrify and maintain 4-8 cell and blastocyst stage human embryos.

Source page: https://510kreport.com/device/K140207
Methodology: https://510kreport.com/methodology