# K162833: VitriGuard

- Pathway: 510(k) (Traditional)
- Applicant: Origio A/S
- Decided: Feb 16, 2017 after 128 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- 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: 3 generations back to K041562 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122982: Cryolock, Biotech, Inc. (2014) Summary page 4.

## Most influential descendants
- K180740: VitriGuard (2018), 0 descendants of its own

## Recalls of this device
- Apr 1, 2022 · Class II · Z-1108-2022: Products in this lot may have compromised barrier seals, introducing a risk to sterility.

## Indications for use
VitriGuard is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

Source page: https://510kreport.com/device/K162833
Methodology: https://510kreport.com/methodology