← Back to catalogue

MiniSpacer Dual Spray MDI Adapter 1024, 1025, 1543, 1024A, 1025A, 1543A

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K233553

by Thayer Medical Corporation

Identifiers

510(k) Number
K233553 FDA 510(k)
FDA Product Code
CAF 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 MiniSpacer Dual Spray MDI Adapter is a metered-dose inhaler (MDI) spacer designed to improve aerosol delivery for patients requiring inhaled medications. It facilitates dual-spray activation, allowing simultaneous administration of two inhalations per trigger pull, which enhances medication deposition in the respiratory tract.

This device is intended for use in clinical and home settings to assist patients with asthma or other respiratory conditions in administering inhaled therapies. Supplied as a reusable medical device, it requires cleaning and maintenance as per manufacturer guidelines. Authorised under FDA 510K clearance (K233553) and MDD compliance, it adheres to regulatory standards for metered-dose inhaler accessories.

Frequently asked questions

What is the primary benefit of the dual-spray feature on the MiniSpacer® MDI Adapter compared to standard spacers?

The MiniSpacer® Dual Spray MDI Adapter is designed to allow simultaneous administration of two inhalations with a single trigger pull, which significantly improves medication deposition in the respiratory tract. This dual-spray capability enhances efficiency for patients requiring inhaled therapies, particularly those with conditions like asthma or other respiratory disorders, by reducing the number of activations needed while delivering consistent doses.

Is the MiniSpacer® MDI Adapter intended for single-use or reusable applications, and what maintenance is required?

The MiniSpacer® MDI Adapter is a reusable medical device, meaning it is designed for repeated use by the same patient. However, it requires regular cleaning and maintenance as outlined in the manufacturer’s guidelines to ensure proper functionality and hygiene. This distinction is important for clinical and home settings where durability and repeated use are priorities.

How does the MiniSpacer® Dual Spray MDI Adapter differ from other MDI spacers in terms of regulatory compliance?

The MiniSpacer® Dual Spray MDI Adapter holds both FDA 510(k) clearance (K233553) and compliance with the Medical Device Directive (MDD), confirming its adherence to stringent regulatory standards for metered-dose inhaler accessories. This dual authorization ensures it meets safety and performance requirements for use in both clinical and home settings across regulated markets.

What types of respiratory conditions is the MiniSpacer® MDI Adapter specifically designed to assist with?

While the device is not limited to a single condition, the MiniSpacer® Dual Spray MDI Adapter is particularly beneficial for patients managing asthma or other respiratory conditions that require inhaled therapies. Its dual-spray feature helps optimize medication delivery, making it a practical choice for improving treatment adherence and efficacy in these patient populations.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Thayer Medical Corporation

Sources (2)

  • FDA 510(k) K233553 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026