# K200815: VitriGuard

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Jun 25, 2020 after 87 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: 4 generations back to K041562 (2004). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K181461: Rapid-i™ Kit, Vitrolife Sweden AB (2019) Summary page 4.

## Most influential descendants
- 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
VitriGuard is intended for use as a cryopreservation storage device in vitrification procedures and indicated to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.

Source page: https://510kreport.com/device/K200815
Methodology: https://510kreport.com/methodology