# K093888: Coopdech Endobronchial Blocker Tube

- Pathway: 510(k) (Traditional)
- Applicant: Daiken Medical Co, Ltd.
- Decided: Mar 16, 2010 after 88 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: 3 generations back to K962167 (1997). 6 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071694: Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXX, Daiken Medical Co, Ltd. (2008) Summary page 2.

## Most influential descendants
- K121028: Etview Tracheoscopic Ventilation Tube (TVT (TM)) (2012), 3 descendants of its own
- K152438: ETView VivaSight-SL (TVT) system (2016), 1 descendant of its own
- K251950: Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) (2026), 0 descendants of its own
- K250243: ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) (2025), 0 descendants of its own
- K232580: Disposable Endobronchial Blocker Tube (2023), 0 descendants of its own

## Indications for use
The COOPDECH ENDOBRONCHIAL BLOCKER TUBE is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. Patient Population: Patients requiring one lung isolation. Environment of Use: Hospitals-OR and ICU.

Source page: https://510kreport.com/device/K093888
Methodology: https://510kreport.com/methodology