# PLA: Esophageal Thermal Regulation And Gastric Suctioning Device

- Device class: 2; regulation: 21 CFR 870.5910; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 257 days (middle half 249–264)
- 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)
- 2015: 1
- 2016: 1
- 2017: 2
- 2018: 3
- 2024: 1
- 2025: 1

## Most-cited predicates
- K170009: Esophageal Cooling Device (2017), cited by 2
- DEN140018: Esophageal Cooling Device (2015), cited by 2
- K152450: Esophageal Cooling Device (2016), cited by 2
- K172493: EnsoETM (2017), cited by 2
- K172029: EnsoETM (2018), cited by 1
- K180244: EnsoETM (2018), cited by 1

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