# MNW: Analyzer, Body Composition

- Device class: 2; regulation: 21 CFR 870.2770; FDA's rule: 510(k) required
- FDA decisions: 79
- 510(k) review time 2021–2025: median 422 days (middle half 422–422)
- Recalls: 0 (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)
- 2007: 4
- 2008: 4
- 2009: 4
- 2010: 1
- 2011: 11
- 2012: 4
- 2013: 9
- 2014: 3
- 2015: 1
- 2024: 1

## Most-cited predicates
- K011652: Body Fat Analyzer, Model HBF-306 (2001), cited by 12
- K040778: Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9) (2004), cited by 10
- K002835: Bodystat (2001), cited by 8
- K014009: Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate Scale (2002), cited by 6
- K033157: Tanita Segmental Body Composition Analyzer, Model BC-418 (2004), cited by 4
- K042528: Inbody, Model 3.0 (2005), cited by 3
- K052646: Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20 (2005), cited by 3
- K030203: Long Well LW-6DXX Series Body Fat Analyzer (2003), cited by 3
- K110689: Inbody (2011), cited by 3
- K053556: Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5 (2006), cited by 2

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