# K113566: Optmizer CTS T-Cell Expansion Serum Free Medium

- Pathway: 510(k) (Traditional)
- Applicant: Life Technologies, Inc.
- Decided: Jun 21, 2012 after 202 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: 2 generations back to DEN000008 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Recalls of this device
- May 10, 2018 · Class II · Z-2542-2018: It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer no

## Indications for use
OpTmizer M CTSTM T-Cell Expansion Serum Free 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/K113566
Methodology: https://510kreport.com/methodology