Simex Subglottic Aspiration System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141255 FDA 510(k)
- FDA Product Code
- BTA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Simex Subglottic Aspiration System is a portable, manual or powered aspiration pump designed for the removal of subglottic secretions. It is classified as a Class II medical device under FDA regulation number 878.4780 and is substantially equivalent to a legally marketed predicate device.
The system is supplied as a reusable device and is intended for use in clinical settings such as general and plastic surgery environments. It is not sterile and does not have MRI safety information specified in the data. Storage and handling should follow manufacturer guidelines, and the device is authorized under FDA 510(k) clearance K141255.
Frequently asked questions
What is the Simex Subglottic Aspiration System used for?
The Simex Subglottic Aspiration System is designed for the removal of subglottic secretions and is intended for use in clinical settings such as general and plastic surgery environments. It functions as a portable, manual or powered aspiration pump for this specific purpose.
Is the Simex Subglottic Aspiration System sterile when supplied?
The device is not sterile when supplied, as explicitly stated in the device data. Users must follow manufacturer guidelines for cleaning, disinfection, or sterilization prior to use, depending on the intended clinical application and reuse protocol.
Can the Simex Subglottic Aspiration System be reused?
Yes, the system is supplied as a reusable device, meaning it is designed for multiple uses after appropriate cleaning and maintenance in accordance with the manufacturer’s instructions for reuse in clinical settings.
How is the Simex Subglottic Aspiration System powered or operated?
The Simex Subglottic Aspiration System is a portable device that can be operated either manually or via power, offering flexibility in clinical use depending on the setting and user preference for aspiration of subglottic secretions.
What regulatory pathway was used for the Simex Subglottic Aspiration System?
The device received authorization through the FDA 510(k) pathway, specifically under clearance K141255, and is classified as a Class II medical device under FDA regulation number 878.4780, based on substantial equivalence to a legally marketed predicate device.
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: Simex Medizintechnik GmbH - Subglotisches Sekretabsaugungs System, Simex - Startseite, PDF Automated subglottic aspiration system simex cuff M & cuff S
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141255 | Class II | Active |
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Manufacturer
- Manufacturer
- Simex Medizintechnik GmbH
Sources (1)
- FDA 510(k) K141255 24 fields · synced Sep 19, 2026