# K931163: Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: Jun 23, 1993 after 107 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 12 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 4 cite it directly.
2 of 28 devices 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.

## Most influential descendants
- 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
- K093126: Anapnoguard Endotracheal Tube (2010), 3 descendants of its own

## Recalls of this device
- May 25, 2023 · Class I · Z-1945-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1877-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1940-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1948-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1950-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1949-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1947-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1942-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1941-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1944-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1946-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1943-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Source page: https://510kreport.com/device/K931163
Methodology: https://510kreport.com/methodology