# K951091: Rusch Endobronchial Tube Sets

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Jun 8, 1995 after 91 days
- Product code: BTS (Tube, Bronchial (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5720
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Nov 21, 2014 · Class II · Z-2407-2015: Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- Nov 21, 2014 · Class II · Z-2411-2015: Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- Nov 21, 2014 · Class II · Z-2413-2015: Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- Nov 21, 2014 · Class II · Z-2415-2015: Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- Nov 21, 2014 · Class II · Z-2414-2015: Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- Nov 21, 2014 · Class II · Z-2410-2015: Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- Nov 21, 2014 · Class II · Z-2408-2015: Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- Nov 21, 2014 · Class II · Z-2412-2015: Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- Nov 21, 2014 · Class II · Z-2409-2015: Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- Feb 28, 2014 · Class II · Z-1231-2014: The product may fail to achieve seal of right lung due to the cuff inflating to one side

Source page: https://510kreport.com/device/K951091
Methodology: https://510kreport.com/methodology