# K935842: Rusch Lasertubus/Rusch Laser Resistant Cuffed with Murphy Eye

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: May 23, 1995 after 532 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 7 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- May 29, 2020 · Class II · Z-2533-2020: Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence
- Apr 1, 2019 · Class II · Z-1685-2019: The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- Apr 1, 2019 · Class II · Z-1684-2019: The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- Apr 1, 2019 · Class II · Z-1683-2019: The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- Apr 1, 2019 · Class II · Z-1686-2019: The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- Apr 1, 2019 · Class II · Z-1682-2019: The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- May 23, 2014 · Class II · Z-1851-2014: Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Alle

Source page: https://510kreport.com/device/K935842
Methodology: https://510kreport.com/methodology