# K190274: Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Medis Medical Device Co., Ltd.
- Decided: Jul 30, 2019 after 172 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: 9 generations back to K903730 (1990). 40 ancestors in all.
No later device cites it as a predicate yet.
9 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141939: Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with Stylet, Teleflexmedical, Inc. (2014) Summary page 5.
- K160694: Disposable Endotracheal tube, sterile, AccuCuff, Tianjin Medis Medical Device Co., Ltd. (2017) Summary page 5.

## Indications for use
The device is intended for airway management by oral intubation and aid in the removal of subglottic secretions.

Source page: https://510kreport.com/device/K190274
Methodology: https://510kreport.com/methodology