# 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

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Dec 12, 2019 after 30 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K920547 (1992). 47 ancestors in all.
No later device cites it as a predicate yet.
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 6.
- K180034: Weinmann Tracheostomy Exchange Set, Cook Incorporated (2018) Summary page 6.

## Recalls of this device
- Mar 5, 2026 · Class II · Z-1780-2026: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Mar 5, 2026 · Class II · Z-1779-2026: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Apr 7, 2023 · Class I · Z-1427-2023: There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an
- Apr 7, 2023 · Class I · Z-1428-2023: There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an

## Indications for use
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel. Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel. Weinmann-Multi Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.

Source page: https://510kreport.com/device/K193133
Methodology: https://510kreport.com/methodology