# K232580: Disposable Endobronchial Blocker Tube

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Insighters Medical Technology Co., Ltd.
- Decided: Dec 14, 2023 after 111 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: 4 generations back to K962167 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093888: Coopdech Endobronchial Blocker Tube, Daiken Medical Co, Ltd. (2010) Summary page 6.

## Indications for use
The Disposable Endobronchial Blocker Tube is intended to differentially intubate a patient’s bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The SFr Endobronchial Blocker Tube is indicated for infants populations; The 7Fr Endobronchial Blocker Tube is indicated for children populations; The 9Fr Endobronchial Blocker Tube is indicated for adults use only. Patient Population: Patients requiring one lung isolation. Environment of Use: Hospitals-OR and ICU.

Source page: https://510kreport.com/device/K232580
Methodology: https://510kreport.com/methodology