# K132815: Puregraft 50 System

- Pathway: 510(k) (Traditional)
- Applicant: Cytori Therapeutics, Inc.
- Decided: Jan 24, 2014 after 137 days
- Product code: MUU (System, Suction, Lipoplasty)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K910696 (1991). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092923: Cytori Puregraft 250/Pure System, Cytori Therapeutics, Inc. (2010) Summary page 3.
- K113255: Puregraft 850/Pure System, Cytori Therapeutics, Inc. (2012) Summary page 3.

## Indications for use
The Puregraft 50 System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.

Source page: https://510kreport.com/device/K132815
Methodology: https://510kreport.com/methodology