# K193285: V-Onestep

- Pathway: 510(k) (Traditional)
- Applicant: Vitromed GmbH
- Decided: Nov 20, 2020 after 359 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: 5 generations back to K034063 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191063: 1-Step Culture Medium, Shenzhen Vitavitro Biotech Co., Ltd. (2019) Summary page 4.

## Indications for use
V-ONESTEP is intended for the in vitro culture of human embryos following fertilization until day 5/6 of development

Source page: https://510kreport.com/device/K193285
Methodology: https://510kreport.com/methodology