Spiro Speaking Valve with Oxygen Port, Spiro Speaking Valve without Oxygen Port
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122932 FDA 510(k)
- FDA Product Code
- JOH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5800 FDA 510(k)
- Regulation Number
- 868.5800 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Spiro Speaking Valve is a tracheostomy tube accessory designed to facilitate speech and airway management in patients with tracheostomies. It functions as a one-way valve, allowing exhaled air to pass through the vocal cords while preventing inhalation through the tracheostomy tube, thereby enabling verbal communication. The device may optionally include an oxygen port for supplemental oxygen delivery.
These valves are supplied as single-use disposable devices, intended for use in clinical settings such as hospitals and intensive care units. They are classified as Class II medical devices under FDA regulations and comply with MDR requirements. The Spiro Speaking Valve is non-magnetic and MRI-safe, ensuring compatibility with magnetic resonance imaging procedures. Sizes and configurations are standardized for tracheostomy tube compatibility, and sterility is maintained through manufacturer packaging.
Frequently asked questions
What is the primary purpose of the Spiro Speaking Valve, and how does it enable speech for tracheostomy patients?
The Spiro Speaking Valve is designed to facilitate speech in patients with tracheostomies by acting as a one-way valve. It allows exhaled air to pass through the vocal cords while blocking inhalation through the tracheostomy tube, enabling verbal communication. This is particularly useful in clinical settings like hospitals and intensive care units where patients may rely on tracheostomy tubes for airway management.
Are the Spiro Speaking Valves reusable or single-use, and how is sterility maintained?
The Spiro Speaking Valves are supplied as single-use disposable devices. Sterility is maintained through manufacturer packaging, ensuring each unit is sterile and ready for immediate clinical use without the need for reprocessing or reuse.
Can the Spiro Speaking Valve be used during MRI procedures, and why is this important?
Yes, the Spiro Speaking Valve is non-magnetic and MRI-safe, meaning it can be used during magnetic resonance imaging procedures without interference or safety risks. This is important for patients who require both tracheostomy management and MRI scans, as it ensures compatibility and avoids complications during imaging.
What configurations are available for the Spiro Speaking Valve, and how do they differ?
The Spiro Speaking Valve is available in two configurations: with and without an oxygen port. The version with an oxygen port allows for supplemental oxygen delivery, which may be beneficial for patients requiring additional oxygen support alongside speech rehabilitation. Both versions are designed to be compatible with standardized tracheostomy tube sizes.
How was the regulatory pathway for the Spiro Speaking Valve determined, and what does this mean for buyers?
The Spiro Speaking Valve was determined to be *substantially equivalent* to a predicate device through a traditional 510(k) clearance process, reviewed by the FDA’s Anesthesiology Advisory Committee. This means the device meets FDA requirements for safety and effectiveness as a Class II medical device, ensuring it adheres to rigorous regulatory standards before market authorization. Buyers can trust it has undergone thorough evaluation for clinical 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: foglesshealth.com, About SPIRO Respiratory Speech Valves I Parburch Medical, SPIRO - Improving the quality of life for tracheostomy patients. - FOGLESS
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K122932 | Class II | Active |
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Manufacturer
- Manufacturer
- Fogless International Ab
Sources (2)
- FDA 510(k) K122932 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026