# K211543: Wei Nasal Jet Tube

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Jul 21, 2022 after 428 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 K802505 (1981). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040657: Boussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 and 6502.70/75/80, Vygon SA (2004) Summary page 5.

## Indications for use
WEI nasal jet tube is indication for airway management, inserted through nasal cavity. During and after insertion, the Jet Tube can supply jet ventilation intermittently. When the Jet tube is not in use, the main tube serves as the main oxygen supply channel, and oxygen is supplied through main tube. The PetCO2 Monitor tube can connect to CO2 monitoring machine to monitor CO2 status.

Source page: https://510kreport.com/device/K211543
Methodology: https://510kreport.com/methodology