# KLA: Monitor, Esophageal Motility, Anorectal Motility, And Tube

- Device class: 2; regulation: 21 CFR 876.1725; FDA's rule: 510(k) required
- FDA decisions: 31
- 510(k) review time 2021–2025: median 123 days (middle half 121–142)
- 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)
- 2002: 1
- 2003: 2
- 2004: 1
- 2007: 1
- 2012: 1
- 2015: 1
- 2017: 1
- 2018: 1
- 2024: 2
- 2025: 1

## Most-cited predicates
- K180135: THD Anopress with THD SensyProbe (2018), cited by 3
- K120088: Mcompass Anorectal Manometry System (2012), cited by 3
- K022023: Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500 (2003), cited by 3
- K872712: PC Polygraf (1988), cited by 2
- K013704: Mediplus Single Use GI Manometry Catheter (2002), cited by 2
- K821588: Sandhill DMS (1982), cited by 1
- K961070: Esophageal Manometry Analysis Module (1996), cited by 1
- K884527: Zinetics (R) Emc (1989), cited by 1
- K031617: Mediplus Single Use Lower GI Manometry Catheter (2004), cited by 1
- K161785: THD Anopress (2017), cited by 1

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