# K092923: Cytori Puregraft 250/Pure System

- Pathway: 510(k) (Traditional)
- Applicant: Cytori Therapeutics, Inc.
- Decided: Jan 6, 2010 after 105 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: 7 generations back to K910696 (1991). 30 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K072587: Cytori Aft System, Cytori Therapeutics, Inc. (2007) Summary page 4.
- K050797: Tissu-Trans, Shippert Medical Technologies Corp. (2005) Summary page 4.
- K081848: Lipose Fat Transfer System, Lipose Corp. (2008) Summary page 4.

## Most influential descendants
- K113255: Puregraft 850/Pure System (2012), 1 descendant of its own
- K132815: Puregraft 50 System (2014), 0 descendants of its own

## Indications for use
The Cytori PureGraft 250/PUR-E 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/K092923
Methodology: https://510kreport.com/methodology