# K232529: Disposable Double Lumen Endobronchial Tube

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Insighters Medical Technology Co., Ltd.
- Decided: May 13, 2024 after 266 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: 8 generations back to K822082 (1982). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203749: Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable, Ambu A/S (2021) Summary page 6.

## Indications for use
The Disposable Double Lumen Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. It 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. The Disposable Double Lumen Endobronchial Tube is indicated for adults use only.

Source page: https://510kreport.com/device/K232529
Methodology: https://510kreport.com/methodology