# OBH: Monitor, Extracellular Fluid, Lymphedema, Extremity

- Device class: 2; regulation: 21 CFR 870.2770; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 77 days (middle half 72–83)
- Recalls: 1 (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: 1
- 2008: 1
- 2011: 1
- 2013: 1
- 2015: 1
- 2017: 1
- 2018: 1
- 2022: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K130338: Impedimed - Bis Extra Cellular Fluid Analysis (2013), cited by 2
- K080825: Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 (2008), cited by 2
- K172122: SOZO (2017), cited by 1
- K143310: MoisturemeterD (2015), cited by 1
- K100811: Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 (2011), cited by 1
- K180126: SOZO (2018), cited by 1
- K050415: Impedimed-Extracellular Fluid Analysis (2007), cited by 1

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