# K100367: Medicult Vitrification Cooling/Warming, Model Ref: 1228, 1229

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Aug 27, 2010 after 196 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 3 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 2.

## Recalls of this device
- Sep 8, 2020 · Class II · Z-0100-2021: There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/

## Indications for use
MediCuit Vitrification Cooling Is for vitrification of human, day 3 cleavage-stage embryos. MediCult Vitrification Warming Is for warming vitrified human, day 3 cleavage-stage embryos.

Source page: https://510kreport.com/device/K100367
Methodology: https://510kreport.com/methodology