# K033101: G-PGD

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: May 7, 2004 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: 1 generation back to K021358 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021358: Embryo Biopsy Medium, Irvine Scientific Sales Co., Inc. (2002) Summary page 1.

## Indications for use
Medium for embryo biopsy

Source page: https://510kreport.com/device/K033101
Methodology: https://510kreport.com/methodology