# K931166: Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EY

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: Jun 22, 1993 after 106 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 9 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
1 of 6 devices in its family (counting itself) has 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
- K041311: Tiger Endotracheal Tubes (Various Models and Sizes) (2005), 2 descendants of its own
- K160694: Disposable Endotracheal tube, sterile, AccuCuff (2017), 1 descendant of its own
- K021540: Rusch Edgar Tube (2002), 1 descendant of its own
- K190274: Endotracheal Tube (2019), 0 descendants of its own
- K023964: Rusch Microlaryngeal Tube (2002), 0 descendants of its own

## Recalls of this device
- May 25, 2023 · Class I · Z-1867-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1866-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1863-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1865-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1862-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1861-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1869-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1868-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- May 25, 2023 · Class I · Z-1864-2023: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Source page: https://510kreport.com/device/K931166
Methodology: https://510kreport.com/methodology