# K232543: MSC SFM

- Pathway: 510(k) (Traditional)
- Applicant: Yocon Biology Technology Company
- Decided: Sep 6, 2024 after 381 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: 4 generations back to DEN000008 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103302: Stempro MSC SFM, Life Technologies Corporation (2011) Summary page 5.

## Indications for use
MSC SFM is a liquid tissue culture medium product intended for human ex-vivo tissue and cell culture processing applications.

Source page: https://510kreport.com/device/K232543
Methodology: https://510kreport.com/methodology