# K871204: Cuffed Tracheal Tube (Multiple)

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Critical Care
- Decided: Apr 21, 1987 after 27 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.
16 later devices descend from it; 5 cite it directly.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K082520: Sealguard Evac Endotracheal and Endotracheal Tubes (2008), 11 descendants of its own
- K090352: Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes (2009), 6 descendants of its own
- K093126: Anapnoguard Endotracheal Tube (2010), 3 descendants of its own
- K150157: AnapnoGuard 100 Respiratory Guard System (2016), 2 descendants of its own
- K110269: Well Lead Endotracheal Tube with Evacuation Lumen-Oral (2011), 2 descendants of its own

## Recalls of this device
- Feb 10, 2023 · Class II · Z-1318-2023: Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.

Source page: https://510kreport.com/device/K871204
Methodology: https://510kreport.com/methodology