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Filtered Mouthpiece Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K220145

by Monaghan Medical Corporation

Identifiers

510(k) Number
K220145 FDA 510(k)
FDA Product Code
CAF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5630 FDA 510(k)
Regulation Number
868.5630 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Filtered Mouthpiece Kit is a filtered mouthpiece assembly designed to connect to small-volume nebulizers. It functions as a barrier to contain exhaled emissions, reducing airborne transmission of viruses (with a filtration efficiency of 99.997%), bacteria (99.9997%), and undelivered medication during respiratory treatments. This device is classified under the anesthesiology product code and is intended for use with nebulizers to improve treatment safety.

This kit is supplied as a single-use accessory for hospital, home, or clinic settings and is intended for patients aged five years and older. It includes a one-way valved tee and filter assembly, with the model reference 60050T. The device is FDA 510(k) cleared under the CAF product code and is intended for use with compatible nebulizers. No additional sterility or MRI safety information is provided in the specifications.

Frequently asked questions

What is the primary purpose of the Monaghan Medical filtered mouthpiece kit, and how does it improve respiratory treatments?

The Monaghan Medical filtered mouthpiece kit is designed to connect to small-volume nebulizers and acts as a barrier to contain exhaled emissions during respiratory treatments. It significantly reduces airborne transmission of viruses (with a filtration efficiency of 99.997%), bacteria (99.9997%), and undelivered medication, enhancing treatment safety for patients aged five and older in hospital, home, or clinic settings.

Is the Monaghan Medical filtered mouthpiece kit reusable, or is it intended for single-use only?

The Monaghan Medical filtered mouthpiece kit is explicitly supplied as a single-use accessory. This design choice ensures hygiene and safety, particularly in clinical settings where contamination risks must be minimized.

What model reference does the Monaghan Medical filtered mouthpiece kit have, and is it compatible with all nebulizers?

The kit carries the model reference 60050T and is intended for use with compatible nebulizers—meaning it is specifically designed to connect to small-volume nebulizers, though not every nebulizer may fit. Always verify compatibility with your existing equipment before use.

How does the filtration efficiency of this kit compare to standard nebulizer mouthpieces, and what does that mean for patient safety?

The kit achieves 99.997% filtration efficiency for viruses and 99.9997% for bacteria, far exceeding typical nebulizer mouthpieces, which often lack such precise filtration. This drastically reduces the risk of airborne contamination during treatments, making it ideal for environments where infection control is critical.

Does the Monaghan Medical filtered mouthpiece kit require any special storage conditions, and is it sterile upon arrival?

The provided specifications do not explicitly mention sterility or special storage requirements for the Monaghan Medical filtered mouthpiece kit. However, as a single-use medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Filtered Mouthpiece Kit - Monaghan Medical, PDF FILTERED MOUTHPIECE KIT - Monaghan Medical, PDF The Monaghan FILTERED MOUTHPIECE KIT Advantage - Tri-anim

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Monaghan Medical Corporation

Sources (1)

  • FDA 510(k) K220145 24 fields · synced Sep 19, 2026