# K100616: Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618

- Pathway: 510(k) (Traditional)
- Applicant: Life Technologies Corporation
- Decided: May 20, 2010 after 77 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: 2 generations back to DEN000008 (2001). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022086: Aim-V (R) Medium, Model 087-0112, Invitrogen Corporation (2002) Summary page 1.

## Most influential descendants
- K103302: Stempro MSC SFM (2011), 1 descendant of its own
- K232543: MSC SFM (2024), 0 descendants of its own
- K240247: “MoFi” Cell Culture Basal Medium (2024), 0 descendants of its own

## Indications for use
Knockout™ SR Medium and Knockout™ SR Xenofree Medium are liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.

Source page: https://510kreport.com/device/K100616
Methodology: https://510kreport.com/methodology