LiteAire Basic Dual-Valved Collapsible MDI Holding Chamber
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210558 FDA 510(k)
- FDA Product Code
- NVP 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 LiteAire Basic Dual-Valved Collapsible MDI Holding Chamber is a Holding Chamber, Direct Patient Interface designed to improve the delivery of metered-dose inhaler (MDI) medications. It features a collapsible, dual-valved construction to enhance medication efficiency and reduce waste by preventing premature actuation of the inhaler.
This device is supplied as a single-use, non-sterile paperboard chamber and is intended for use in respiratory care settings. It is classified under FDA regulation 868.5630 and has received FDA 510(k) clearance and MDD compliance. The chamber is lightweight and portable, offering a cost-effective alternative to rigid plastic holding chambers while maintaining effective drug output.
Frequently asked questions
What is the primary purpose of the LiteAire Basic Dual-Valved Collapsible MDI Holding Chamber and how does it improve medication delivery?
The LiteAire Basic Dual-Valved Collapsible MDI Holding Chamber is designed to enhance the delivery of metered-dose inhaler (MDI) medications by reducing medication waste and improving efficiency. Its dual-valved, collapsible construction helps prevent premature actuation of the inhaler, ensuring more of the medication reaches the patient’s lungs rather than being lost in the environment.
Is this device reusable or intended for single-use, and what material is it made from?
The LiteAire Basic Dual-Valved Collapsible MDI Holding Chamber is explicitly supplied as a single-use device. It is made from non-sterile paperboard, which makes it lightweight, portable, and cost-effective for respiratory care settings.
What sizes or models are available for this holding chamber, and how does it compare to rigid plastic alternatives?
The device data does not specify exact size variations, but it is described as a collapsible design, which implies flexibility in fitting different patient needs while maintaining portability. Unlike rigid plastic holding chambers, this paperboard version offers a lighter, more compact alternative without compromising drug output efficiency, making it a budget-friendly option.
How should the LiteAire Basic Dual-Valved Holding Chamber be stored, and is it suitable for clinical or home use?
While the device is non-sterile and intended for respiratory care settings, storage instructions are not detailed in the provided data. However, as a single-use, paperboard product, it should be kept in a dry, clean environment to prevent damage before use. Its lightweight and portable design suggests it could be practical for both clinical and home use, though clinical settings are explicitly mentioned in its intended use.
What regulatory pathways has this device undergone, and which advisory committee was involved in its review?
The LiteAire Basic Dual-Valved Collapsible MDI Holding Chamber has undergone FDA 510(k) clearance (traditional pathway) and MDD compliance (European regulatory route). Its review was conducted under the Anesthesiology (AN) Advisory Committee, though this classification relates to the submission’s filing category rather than its clinical indication.
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: Thayer Medical LiteAire® MDI holding Chamber, Thayer Medical | Products for Respiratory Care | MDI Holding Chambers ..., LiteAire - Timik Group, LiteAire MDI Holding Chamber, Dual-Valved - Betty Mills
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210558 | Class II | Active |
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Manufacturer
- Manufacturer
- Thayer Medical Corporation
Sources (2)
- FDA 510(k) K210558 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026