# K051522: Silbroncho Double Lumen Tube

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Systems Corp.
- Decided: Aug 17, 2005 after 70 days
- Product code: CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771219 (1977). 2 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771219: Broncho-Cath, Mallinckrodt Critical Care (1977) Summary page 1.
- K932647: Wire Reinforced Endotracheal Tube, Vitaid, Ltd. (1993) Summary page 1.

## Most influential descendants
- K092886: Well Lead Endobronchial Tubes (2010), 10 descendants of its own
- K113576: Double Lumen Video Tracheosdope (DLVT) System (2012), 4 descendants of its own
- K123853: Vivasight-DL System (2013), 3 descendants of its own
- K181886: VivaSight-DL System (2018), 2 descendants of its own
- K141888: Rusch Endobronchial Tubes (2015), 2 descendants of its own

## Indications for use
The Silbroncho® is used to isolate the left or the right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

Source page: https://510kreport.com/device/K051522
Methodology: https://510kreport.com/methodology