# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Tappa Medical Technology Co., Ltd.
- Decided: Mar 20, 2026 after 268 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160542: 5.0 Fr Arndt Endobronchial Blocker Set, Cook Incorporated (2016) Summary page 5.
- K021920: 7.0 FR. Endobronchial Blocker, Cook, Inc. (2002) Summary page 5.
- K093888: Coopdech Endobronchial Blocker Tube, Daiken Medical Co, Ltd. (2010) Summary page 5.

## Indications for use
The 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 5Fr Endobronchial Blocker Tube is indicated for pediatric populations, in children with minimum 10 Kg of weight. All other sizes are for adult use only.

Source page: https://510kreport.com/device/K251950
Methodology: https://510kreport.com/methodology