# K113255: Puregraft 850/Pure System

- Pathway: 510(k) (Traditional)
- Applicant: Cytori Therapeutics, Inc.
- Decided: Mar 7, 2012 after 125 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: 8 generations back to K910696 (1991). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 4.

## Most influential descendants
- K132815: Puregraft 50 System (2014), 0 descendants of its own

## Indications for use
The Puregraft® 850/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the sane patient for aesthetic body contouring.

Source page: https://510kreport.com/device/K113255
Methodology: https://510kreport.com/methodology