# FCX: Insufflator, Automatic Carbon-Dioxide For Endoscope

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 25
- 510(k) review time 2021–2025: median 217 days (middle half 124–250)
- Recalls: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 1
- 2014: 2
- 2016: 1
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2023: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K053008: E-Z-EM Endoscopic CO2 Regulator (2005), cited by 6
- K030854: PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400 (2003), cited by 3
- K111648: Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator (2011), cited by 3
- K013219: PROTOCO2L Insufflator Model 6400 (2002), cited by 2
- K132192: Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator (2014), cited by 1
- K063786: Endoscopic Insufflation Unit, Model Xecr-2 (2007), cited by 1
- K230474: EVA5 Insufflator (2023), cited by 1
- K133976: Fujifilm Endoscopic CO2 Regulator (2014), cited by 1
- K881004: Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr (1988), cited by 1

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