# CBI: Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

- Device class: 2; regulation: 21 CFR 868.5740; FDA's rule: 510(k) required
- FDA decisions: 34
- 510(k) review time 2021–2025: median 131 days (middle half 120–266)
- Recalls: 4 (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)
- 2013: 1
- 2015: 1
- 2016: 2
- 2018: 2
- 2020: 1
- 2021: 2
- 2022: 1
- 2023: 1
- 2024: 1
- 2026: 2

## Most-cited predicates
- K092886: Well Lead Endobronchial Tubes (2010), cited by 5
- K021920: 7.0 FR. Endobronchial Blocker (2002), cited by 5
- K051522: Silbroncho Double Lumen Tube (2005), cited by 4
- K962167: Bronchial Blocker (1997), cited by 3
- K002288: Arndt Pediatric Endobronchial Blocker (2000), cited by 3
- K093888: Coopdech Endobronchial Blocker Tube (2010), cited by 3
- K071694: Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXX (2008), cited by 2
- K203749: Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (2021), cited by 1
- K123853: Vivasight-DL System (2013), cited by 1
- K894337: Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM (1989), cited by 1

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