# MUU: System, Suction, Lipoplasty

- Device class: 2; regulation: 21 CFR 878.5040; FDA's rule: 510(k) required
- FDA decisions: 40
- 510(k) review time 2021–2025: median 197 days (middle half 192–292)
- Recalls: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 1
- 2014: 4
- 2015: 3
- 2016: 1
- 2017: 7
- 2018: 1
- 2019: 4
- 2020: 2
- 2021: 2
- 2022: 1

## Most-cited predicates
- K121005: Adiprep Adipose Transfer System (2012), cited by 7
- K072587: Cytori Aft System (2007), cited by 6
- K120902: GID 700 (2012), cited by 5
- K081848: Lipose Fat Transfer System (2008), cited by 4
- K092482: Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 (2009), cited by 4
- K161636: Lipogems System (2016), cited by 3
- K100114: Fat Concentration System (2010), cited by 3
- K092284: Lipisystems Aquavage, Models AV2000 and AV1200 (2009), cited by 2
- K092923: Cytori Puregraft 250/Pure System (2010), cited by 2
- K083455: Lipokit with Disposable 50CC Aft Syringe, Model ZLK-100 (2009), cited by 2

Source page: https://510kreport.com/product-code/MUU
Data by year (CSV): https://510kreport.com/product-code/MUU.csv