# K090352: Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Apr 3, 2009 after 51 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871204 (1987). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871204: Cuffed Tracheal Tube (Multiple), Mallinckrodt Critical Care (1987) Summary page 2.
- K965132: HI-LO Evac and Evac II Endotracheal Tubes, Mallinckrodt Medical (1997) Summary page 2.
- K082520: Sealguard Evac Endotracheal and Endotracheal Tubes, Mallinckrodt Medical (2008) Summary page 2.

## Most influential descendants
- K110269: Well Lead Endotracheal Tube with Evacuation Lumen-Oral (2011), 2 descendants of its own
- K120985: Kimvent Microcuff Subglottic Suctioning (2012), 1 descendant of its own
- K190878: Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff (2020), 0 descendants of its own
- K182739: Endotracheal Tube with Evacuation Lumen (2019), 0 descendants of its own
- K172208: NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet (2018), 0 descendants of its own

## Indications for use
The TaperGuard Evacm Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea, and for evacuation or drainage of the subglottic space. The TaperGuard"' Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.

Source page: https://510kreport.com/device/K090352
Methodology: https://510kreport.com/methodology