# K851856: Tracheal/Bronchial Differential Ventilation Tube

- Pathway: 510(k) (Traditional)
- Applicant: Sheridan Catheter Corp.
- Decided: May 23, 1985 after 27 days
- Product code: CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5740
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
2 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961977: Kendall Sher-I-Bronch Endobrochial Tube (1996), 0 descendants of its own

## Recalls of this device
- Oct 30, 2019 · Class II · Z-0703-2020: The tracheal and brochial swivel connectors are incorrectly labeled.
- Jun 1, 2015 · Class I · Z-2368-2015: The double swivel connector may crack or separate on the endobronchial tube.
- Feb 23, 2005 · Not classified · Z-0680-05: The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-16137 stating 'Bronchia
- Feb 23, 2005 · Not classified · Z-0681-05: The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-16137 stating 'Bronchia

Source page: https://510kreport.com/device/K851856
Methodology: https://510kreport.com/methodology