# K123853: Vivasight-DL System

- Pathway: 510(k) (Traditional)
- Applicant: Etview, Ltd.
- Decided: Apr 15, 2013 after 122 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: 5 generations back to K822082 (1982). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113576: Double Lumen Video Tracheosdope (DLVT) System, Etview, Ltd. (2012) Summary page 2.
- K092886: Well Lead Endobronchial Tubes, Well Lead Instruments (2010) Summary page 2.
- K051522: Silbroncho Double Lumen Tube, Fuji Systems Corp. (2005) Summary page 2.

## Most influential descendants
- K181886: VivaSight-DL System (2018), 2 descendants of its own
- K203749: Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (2021), 1 descendant of its own
- K232529: Disposable Double Lumen Endobronchial Tube (2024), 0 descendants of its own

## Indications for use
The ETView VivaSight-DLT System is intended to isolate the left or right lung of a patient for intensive care or surgery, one lung ventilation or one lung anesthesia. The VivaSight-DLT System is indicated for verifying tube placement and repositioning.

Source page: https://510kreport.com/device/K123853
Methodology: https://510kreport.com/methodology