# K103302: Stempro MSC SFM

- Pathway: 510(k) (Traditional)
- Applicant: Life Technologies Corporation
- Decided: Feb 18, 2011 after 101 days
- Product code: NDS (Media, Culture, Ex Vivo, Tissue And Cell)
- Device class: 2
- Regulation: 21 CFR 876.5885
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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 1.

## Most influential descendants
- K232543: MSC SFM (2024), 0 descendants of its own

## Recalls of this device
- Jun 11, 2019 · Class II · Z-0274-2020: Component was not tested by the supplier for adventitious agents

## Indications for use
StemPro® MSC SFM Medium is a liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.

Source page: https://510kreport.com/device/K103302
Methodology: https://510kreport.com/methodology