# K961837: Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Aug 16, 1996 after 95 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 36 (32 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 5 cite it directly.
3 of 31 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) Sheridan HVT (TM) Tracheal Tube with X-Ray Line and 15mm. Connector High Volume Tapered Low Pressure Murphy Eye: named in the summary without a submission number

## Most influential descendants
- K993786: Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy (2000), 29 descendants of its own
- K042683: Well Lead Endotracheal Tube (2005), 23 descendants of its own
- K111401: Bever Endotracheal Tube, Bever Eva Endotracheal Tube (2012), 5 descendants of its own
- K073383: Well Lead Reinforced Endotracheal Tube (2008), 5 descendants of its own
- K151381: Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye (2015), 3 descendants of its own

## Recalls of this device
- May 25, 2023 · Class I · Z-1882-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1852-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1886-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1899-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1962-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1881-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1960-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1961-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1889-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1963-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1890-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1847-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1965-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1892-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1846-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1888-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1958-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1964-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1893-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1849-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1894-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1887-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1850-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1853-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1848-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1959-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1851-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1891-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1883-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1884-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1845-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1885-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- Dec 8, 2022 · Class II · Z-1011-2023: Potential for pilot balloon non-inflation or cuff non-deflation.
- Jul 16, 2021 · Class II · Z-2322-2021: The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
- Jul 16, 2021 · Class II · Z-2321-2021: The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
- Jul 16, 2021 · Class II · Z-2320-2021: The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

## Indications for use
The device is intended for oral or nasal intubation. It is intended for airway management.

Source page: https://510kreport.com/device/K961837
Methodology: https://510kreport.com/methodology