# K240247: “MoFi” Cell Culture Basal Medium

- Pathway: 510(k) (Traditional)
- Applicant: Duogenic Stemcells Corporation
- Decided: Jul 12, 2024 after 164 days
- Product code: NDS (Media, Culture, Ex Vivo, Tissue And Cell)
- Device class: 2
- Regulation: 21 CFR 876.5885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN000008 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100616: Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618, Life Technologies Corporation (2010) Summary page 5.

## Indications for use
MoFi is a liquid culture medium intended for human ex vivo tissue and cell culture processing applications.

Source page: https://510kreport.com/device/K240247
Methodology: https://510kreport.com/methodology