Skip to content

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

by Cook Incorporated

510(k) K193133

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193133↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK193133 Date12 Dec 2019ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1779-2026 FDA Class II initiated 5 Mar 2026
    • Ongoing Z-1780-2026 FDA Class II initiated 5 Mar 2026

    Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  • 2 recalls, same reason

    • Ongoing Z-1427-2023 FDA Class I initiated 7 Apr 2023
    • Ongoing Z-1428-2023 FDA Class I initiated 7 Apr 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 unsecure connection between the device connector and circuit components, cap, or accessories.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
JOH
Device Class
Class II
Regulation
21 CFR Part 868.5800
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Percutaneous Tracheostomy Introducer Set, designed for percutaneous dilational tracheostomy to manage adult airways. It includes introducer trays and exchange sets for creating or exchanging tracheostomy tubes in controlled clinical environments. The sets are intended for use in procedures requiring precise airway access, such as prolonged mechanical ventilation or respiratory failure management.

The Blue Rhino G1 and G2 sets, along with the Weinmann-Multi Exchange Set, are supplied sterile and intended for single-use. Procedures must be performed in a controlled setting, such as an ICU or operating room, with trained personnel. The device complies with FDA 510(k) clearance (K193133) and EU MDR regulations, adhering to Class II medical device standards. Each set includes model-specific components and reference codes for traceability.

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical scenarios is this percutaneous tracheostomy introducer set designed to address?

    This device is specifically designed for creating or exchanging tracheostomy tubes in controlled clinical settings, such as intensive care units (ICUs) or operating rooms. It is intended for procedures requiring precise airway access, particularly for patients undergoing prolonged mechanical ventilation or managing respiratory failure where secure airway management is critical.

  • Are these sets single-use or reusable, and how does that affect their sterility?

    The Blue Rhino G1, G2, and Weinmann-Multi sets are supplied sterile and intended for single-use only. This ensures patient safety by eliminating the risk of cross-contamination between procedures, as each set is packaged and sterilized for one-time use in a sterile field.

  • What regulatory pathways have these devices undergone, and what does that mean for clinicians?

    These devices have received FDA 510(k) clearance (K193133) under a special classification, meaning they were deemed substantially equivalent to a legally marketed predicate device. Additionally, they comply with EU MDR (Medical Device Regulation) standards, classifying them as Class II devices. Clinicians can rely on this regulatory backing, which includes rigorous pre-market evaluations, to ensure safety and performance for percutaneous tracheostomy procedures.

  • What are the key differences between the Blue Rhino G1, G2, and Weinmann-Multi sets?

    The Blue Rhino G1 and G2 sets are distinct models tailored for specific procedural needs, with model-specific components included in each tray. The Weinmann-Multi Exchange Set is designed specifically for exchanging existing tracheostomy tubes rather than creating a new tracheostomy. All three are sterile, single-use, and intended for controlled clinical environments, but their intended use varies between initial placement (G1/G2) and tube exchange (Weinmann-Multi).

  • Where should these sets be stored, and what precautions should be taken before use?

    These sets should be stored in their original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, verify the sterility seal is intact and inspect for any visible damage. Since they are single-use, only open the packaging in a sterile field immediately before the procedure to maintain aseptic technique.