# K191063: 1-Step Culture Medium

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Vitavitro Biotech Co., Ltd.
- Decided: Aug 23, 2019 after 123 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: 4 generations back to K034063 (2004). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K133568: G-TL, Vitrolife, Inc. (2014) Summary page 4.

## Most influential descendants
- K193285: V-Onestep (2020), 0 descendants of its own

## Indications for use
This product is intended for the in vitro culture of human embryos following fertilization until Day 5/6 of development.

Source page: https://510kreport.com/device/K191063
Methodology: https://510kreport.com/methodology