# LGM: Chamber, Patient Isolation

- Device class: 2; regulation: 21 CFR 880.5450; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 247 days (middle half 247–247)
- 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)
- 1986: 1
- 1988: 2
- 1990: 1
- 1992: 1
- 1995: 1
- 2002: 1
- 2009: 1
- 2017: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K790657: Stretcher Transit Isolater #122 (1979), cited by 1

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