# K180034: Weinmann Tracheostomy Exchange Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 7, 2018 after 123 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K920547 (1992). 46 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 48 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133597: Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray, Cook, Inc. (2014) Summary page 4.

## Most influential descendants
- K193133: Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (2019), 0 descendants of its own

## Indications for use
The Weinmann Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange

Source page: https://510kreport.com/device/K180034
Methodology: https://510kreport.com/methodology