# K990619: Rusch Reinforced Endotracheal (or Tracheal) Tube- Cuffed and Uncuffed Murphy/Magill, Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Aug 3, 1999 after 159 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Willy Rusch Reinforced Tracheal Tube: named in the summary without a submission number
- (no number) Sheridan Reinforced Cuffed Tracheal Tube: named in the summary without a submission number
- (no number) SIMS/Portex Reinforced Cuffed Silicone Tracheal Tube: named in the summary without a submission number
- (no number) NCC/Mallinckrodt Reinforced Tracheal Tube Cuffed: named in the summary without a submission number

## Most influential descendants
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own
- K130304: Lma Family of Airways (2014), 4 descendants of its own
- K142103: Cuff Pilot, Sure Seal (2015), 3 descendants of its own
- K160694: Disposable Endotracheal tube, sterile, AccuCuff (2017), 1 descendant of its own
- K242495: LMA Fastrach ETT SU (2025), 0 descendants of its own

## Recalls of this device
- Dec 12, 2014 · Class II · Z-1124-2015: Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff diameter. The actu

## Indications for use
Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.

Source page: https://510kreport.com/device/K990619
Methodology: https://510kreport.com/methodology
