# 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

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs, Inc.
- Decided: Jan 10, 2020 after 281 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: 4 generations back to K961837 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
5 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110269: Well Lead Endotracheal Tube with Evacuation Lumen-Oral, Well Lead Medical Co., Ltd. (2011) Summary page 4.

## Indications for use
The Salter Labs Trach-Vac endotracheal tubes are indicated for nasal or oral intubation of the trachea for anesthesia and airway management, including mechanical ventilation and suctioning of accumulated subglottic secretions in the trachea of adult patients.

Source page: https://510kreport.com/device/K190878
Methodology: https://510kreport.com/methodology