# K092482: Tissu Trans Filtron, Models 3-TT-Filtron 2000-500

- Pathway: 510(k) (Traditional)
- Applicant: Shippert Medical Technologies Corp.
- Decided: Dec 4, 2009 after 113 days
- Product code: MUU (System, Suction, Lipoplasty)
- Device class: 2
- Regulation: 21 CFR 878.5040
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K910696 (1991). 26 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 44 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 3.
- (no number) Genesis Biosystems Lipivage: named in the summary without a submission number

## Most influential descendants
- K120902: GID 700 (2012), 11 descendants of its own
- K142682: The Lipogems System (2014), 6 descendants of its own
- K161636: Lipogems System (2016), 5 descendants of its own
- K171135: Lipogems System (2017), 2 descendants of its own
- K120328: Origins Lipoharvesting System (2012), 2 descendants of its own

## Recalls of this device
- Feb 2, 2018 · Class II · Z-1330-2019: The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
- Feb 2, 2018 · Class II · Z-1331-2019: The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
- Feb 2, 2018 · Class II · Z-1333-2019: 
- Feb 2, 2018 · Class II · Z-1332-2019: The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
- Feb 2, 2018 · Class II · Z-1335-2019: The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
- Feb 2, 2018 · Class II · Z-1336-2019: The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
- Feb 2, 2018 · Class II · Z-1334-2019: 
- Oct 20, 2017 · Class II · Z-0170-2018: Potential breach of sterility of the packaging.

## Indications for use
The Tissu Trans Filtron is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.

Source page: https://510kreport.com/device/K092482
Methodology: https://510kreport.com/methodology