# K112534: Lifecell Tissue Expander

- Pathway: 510(k) (Traditional)
- Applicant: Lifecell Corp.
- Decided: Aug 10, 2012 after 344 days
- Product code: LCJ (Tissue Expander And Accessories)
- Device class: U
- 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 K862203 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102806: Natrelle 133 Tissue Expander with Suture Tabs, Allergan Medical (2011) Summary page 2.

## Indications for use
The LifeCell Tissue Expanders are intended for use in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The LifeCell Tissue Expanders are intended for temporary subdermal implantation and are not intended for use beyond six months.

Source page: https://510kreport.com/device/K112534
Methodology: https://510kreport.com/methodology