Modified 225/SIMV Volume Ventilator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K884389 FDA 510(k)
- FDA Product Code
- CBK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Modified 225/SIMV Volume Ventilator is a ventilator, continuous, facility use designed to provide mechanical ventilation for patients requiring assisted or controlled breathing. It delivers synchronized intermittent mandatory ventilation (SIMV) to support respiratory function in clinical settings, ensuring precise control of tidal volume and respiratory rate.
This device is intended for facility-based use and has received FDA 510(k) clearance under the classification of Class II (CBK product code). It is not described as single-use or reusable in the regulatory data, nor is MRI safety or sterility specified. The device is supplied as a modified version of the original 225 ventilator and is regulated under the U.S. Food and Drug Administration’s premarket notification process.
Frequently asked questions
What type of ventilation does the Modified 225/SIMV Volume Ventilator provide, and where is it intended for use?
The Modified 225/SIMV Volume Ventilator delivers synchronized intermittent mandatory ventilation (SIMV), a mode designed to support patients requiring assisted or controlled breathing. It is specifically intended for facility-based use, meaning it is meant to be operated in clinical settings like hospitals or surgical centers where respiratory support is administered under professional supervision.
Is this ventilator designed for single-use or can it be reused after cleaning and maintenance?
The regulatory data for the Modified 225/SIMV Volume Ventilator does not specify whether it is single-use or reusable. For clinical use, it would depend on the manufacturer’s instructions and facility protocols, as ventilators are typically designed for facility-based reuse with proper cleaning, disinfection, and maintenance procedures. Always follow the manufacturer’s guidelines to ensure safe and effective operation.
What regulatory pathway was followed for FDA clearance of this ventilator, and what does that mean for its use?
The Modified 225/SIMV Volume Ventilator received FDA 510(k) clearance under the classification of Class II (CBK product code), which means it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that the device meets FDA safety and effectiveness requirements for its intended use as a facility-use ventilator in clinical settings, but it does not imply approval for home use or any specific clinical indication beyond mechanical ventilation support.
Are there different models or sizes available for the Modified 225/SIMV Volume Ventilator, and how would I know which one to select?
The provided data does not list specific models or sizes for the Modified 225/SIMV Volume Ventilator, as the focus is on its facility-use design and regulatory classification. To determine the appropriate model or configuration, you would need to consult the manufacturer’s documentation or technical specifications, which may outline variations in tidal volume ranges, pressure settings, or other clinical parameters. For precise selection, contact Monaghan Medical Corp. directly.
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: MODIFIED 225/SIMV VOLUME VENTILATOR - Innolitics, Modified 225/simv Volume Ventilator 510 (k) FDA Premarket Notification ..., PDF K884389 - Modified 225/Simv Volume Ventilator, Monaghan Medical Corporation » Medical Devices for Respiratory Health, MONAGHAN 225 SIMV Price Quote and Product Information
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K884389 | Class II | Active |
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Manufacturer
- Manufacturer
- Monaghan Medical Corp.
Sources (1)
- FDA 510(k) K884389 24 fields · synced Sep 19, 2026