# K961977: Kendall Sher-I-Bronch Endobrochial Tube

- Pathway: 510(k) (Traditional)
- Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
- Decided: Jul 31, 1996 after 72 days
- Product code: CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5740
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771219 (1977). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851856: Tracheal/Bronchial Differential Ventilation Tube, Sheridan Catheter Corp. (1985) Summary page 1.
- K771219: Broncho-Cath, Mallinckrodt Critical Care (1977) Summary page 1.

## Recalls of this device
- Jun 1, 2015 · Class I · Z-2367-2015: The double swivel connector may crack or separate on the endobronchial tube.
- Sep 27, 2006 · Not classified · Z-0125-2007: Biological indicator failed. Investigation eliminated all equipment and product related factors.

## Indications for use
The endobronchial tube is intended for use in thoracic surgery, bronchospirometry, administration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

Source page: https://510kreport.com/device/K961977
Methodology: https://510kreport.com/methodology