AeroChamber2go Anti-Static Valved Holding Chamber
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242667 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 AeroChamber2go Anti-Static Valved Holding Chamber is a Direct Patient Interface device classified as a Holding Chamber. It is designed to improve the delivery of aerosolized medication by acting as an intermediary between a metered-dose inhaler (MDI) and the patient’s respiratory tract, ensuring proper dispersion and inhalation of medication.
This device is intended for single-use in clinical settings, including anesthesiology, and is manufactured with anti-static properties to reduce electrostatic discharge risks. Supplied sterile, it is regulated under FDA 510(k) clearance (K242667) and the Medical Device Directive (MDD), adhering to Class II standards. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What clinical settings is the AeroChamber2go Anti-Static Valved Holding Chamber designed for, and how does it improve medication delivery?
The AeroChamber2go is designed for single-use in clinical settings, including anesthesiology, where it acts as an intermediary between a metered-dose inhaler (MDI) and the patient’s respiratory tract. It improves medication delivery by ensuring proper dispersion and inhalation of aerosolized drugs, helping to enhance the efficiency and accuracy of treatment.
Is the AeroChamber2go Anti-Static Valved Holding Chamber reusable or intended for single-use, and how does this affect its sterility?
The AeroChamber2go is explicitly intended for single-use only in clinical settings. It is supplied sterile, meaning it is manufactured and packaged under controlled conditions to prevent contamination. Since it is not designed for reuse, maintaining sterility is critical—once opened or used, it should not be reused to avoid infection risks.
What special features does the AeroChamber2go have to reduce risks during use, and why is this important in clinical environments?
The AeroChamber2go includes anti-static properties, which minimize the risk of electrostatic discharge—a potential hazard in clinical settings where electronic equipment and dry environments (e.g., operating rooms) are common. This feature helps ensure safe and reliable use when administering aerosolized medications.
How should the AeroChamber2go be stored to maintain its sterility and functionality, and what happens if storage guidelines aren’t followed?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. While the data doesn’t specify exact storage conditions, typical best practices for sterile single-use devices include keeping them in a clean, dry environment, protected from physical damage, and away from direct sunlight or extreme temperatures. Failure to follow storage instructions could compromise sterility, risking contamination or device failure during use.
What regulatory pathways does the AeroChamber2go follow, and how does this affect its use in different markets?
The AeroChamber2go is cleared under the FDA 510(k) pathway (K242667) and complies with the Medical Device Directive (MDD) in Europe, adhering to Class II standards. This means it has undergone regulatory review to demonstrate safety and effectiveness for its intended single-use purpose in clinical settings like anesthesiology. Buyers should confirm local regulatory requirements, as clearance in one market (e.g., FDA) does not automatically apply to others.
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: AeroChamber2go Anti-Static Valved Holding Chamber, AeroChamber2go Anti-Static Valved Holding Chamber (K242667), K242667 - AeroChamber2go Anti-Static Valved Holding Chamber, AeroChamber2go Anti-Static Valved Holding Chamber
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 | K242667 | Class II | Active |
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Manufacturer
- Manufacturer
- Trudell Medical International
Sources (2)
- FDA 510(k) K242667 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026