# K160694: Disposable Endotracheal tube, sterile, AccuCuff

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Medis Medical Device Co., Ltd.
- Decided: Apr 7, 2017 after 389 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: 8 generations back to K903730 (1990). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
7 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042683: Well Lead Endotracheal Tube, Well Lead Medical Instruments (2005) Summary page 5.
- K073383: Well Lead Reinforced Endotracheal Tube, Well Lead Medical Instruments (2008) Summary page 5.
- K041311: Tiger Endotracheal Tubes (Various Models and Sizes), Tiger Medical Products, Ltd. (2005) Summary page 5.
- K142103: Cuff Pilot, Sure Seal, Teleflexmedical, Inc. (2015) Summary page 5.

## Most influential descendants
- K190274: Endotracheal Tube (2019), 0 descendants of its own

## Indications for use
The Sterile Disposable Endotracheal Tube device is intended for oral or nasal intubation and for airway management. The Accu-Cuff device is intended to inflate cuffs and to monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.

Source page: https://510kreport.com/device/K160694
Methodology: https://510kreport.com/methodology