# K021920: 7.0 FR. Endobronchial Blocker

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Aug 14, 2002 after 64 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 K894337 (1989). 3 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 18 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 2.
- K002288: Arndt Pediatric Endobronchial Blocker, Cook, Inc. (2000) Summary page 2.
- K894337: Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM, Vitaid, Ltd. (1989) Summary page 2.

## 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
- K083883: Chartis Catheter (2009), 3 descendants of its own
- K111522: Chartis Catheter Model CHR-CA-12.0 (2011), 2 descendants of its own

## Indications for use
The 7.0 Fr. 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/K021920
Methodology: https://510kreport.com/methodology