# K013865: Tip Deflrcting Endobronchial Blocker

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Apr 22, 2002 after 152 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: 1 generation back to K962167 (1997). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962167: Bronchial Blocker, Cook, Inc. (1997) Summary page 1.
- K002288: Arndt Pediatric Endobronchial Blocker, Cook, Inc. (2000) Summary page 1.

## Most influential descendants
- K071694: Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXX (2008), 8 descendants of its own
- K093888: Coopdech Endobronchial Blocker Tube (2010), 6 descendants of its own
- 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

## Indications for use
The Tip Deflecting Endobronchial Blocker is intended for use to differentially intubate a patient’s bronchus in order to isolate the left or right lung for procedures which require one-lung ventilation.

Source page: https://510kreport.com/device/K013865
Methodology: https://510kreport.com/methodology