# K183486: RapidVit™ Oocyte, RapidWarm™ Oocyte

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Jul 26, 2019 after 221 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: 5 generations back to K000309 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160006: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit, Irvine Scientific (2016) Summary page 4.

## Indications for use
RapidVit™ Oocyte: Media for vitrification of human oocytes (MII). RapidWarm™ Oocyte: Media for warming of vitrified human oocytes (MII).

Source page: https://510kreport.com/device/K183486
Methodology: https://510kreport.com/methodology