# K092886: Well Lead Endobronchial Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Instruments
- Decided: Mar 11, 2010 after 171 days
- Product code: CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5740
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K771219 (1977). 3 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 14 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.
- K051522: Silbroncho Double Lumen Tube, Fuji Systems Corp. (2005) Summary page 1.

## Most influential descendants
- 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
- K203749: Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (2021), 1 descendant of its own

## Recalls of this device
- Dec 16, 2016 · Class II · Z-1399-2017: The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.

## Indications for use
The Well Lead Endobronchial Tube 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/K092886
Methodology: https://510kreport.com/methodology