# K090832: Rapid-I

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Dec 23, 2009 after 272 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: 1 generation back to K041562 (2004). 1 ancestor in all.
17 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041562: Cryotip, Irvine Scientific Sales Co., Inc. (2004) Summary page 1.

## Most influential descendants
- K122982: Cryolock (2014), 8 descendants of its own
- K140207: Rapid-I Kit (2014), 4 descendants of its own
- K181461: Rapid-i™ Kit (2019), 3 descendants of its own
- K153027: Cryotop US (2016), 3 descendants of its own
- K200815: VitriGuard (2020), 2 descendants of its own

## Indications for use
Rapid-iTM is a cryopreservation device indicated to be used to contain, vitrify and maintain 4-8 cell stage embryos

Source page: https://510kreport.com/device/K090832
Methodology: https://510kreport.com/methodology