# JEH: Plethysmograph, Volume

- Device class: 2; regulation: 21 CFR 868.1760; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 213 days (middle half 184–241)
- 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)
- 1985: 1
- 1993: 1
- 1994: 1
- 1995: 3
- 1997: 1
- 2003: 1
- 2008: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K072061: Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body (2008), cited by 4
- K022636: Body Box 5500 (2003), cited by 1
- K936108: Masterscreen Body (1995), cited by 1

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