# K203749: Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: May 3, 2021 after 131 days
- Product code: CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5740
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K822082 (1982). 12 ancestors in all.
1 later device descends 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)
- K181886: VivaSight-DL System, Etview, Ltd. (2018) Summary page 4.

## Most influential descendants
- K232529: Disposable Double Lumen Endobronchial Tube (2024), 0 descendants of its own

## Recalls of this device
- Sep 16, 2024 · Class II · Z-0261-2025: Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential 
- Jun 3, 2022 · Class II · Z-1420-2022: Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation

## Indications for use
Intubation with Ambu VivaSight 2 DLT is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.

Source page: https://510kreport.com/device/K203749
Methodology: https://510kreport.com/methodology