INSPIRX, INC

Inspirix, Inc. specializes in reusable medicine chamber spacers, specifically valved holding chambers. These devices are designed to enhance the delivery of inhaled medications, such as those from metered-dose inhalers, by acting as a spacer between the inhaler and the patient’s mouth or nose. The company offers standard valved holding chambers as well as variants paired with different mask attachments, like the InspiraMask and SootherMask in various sizes.

Inspirix, Inc. is based in the United States, which means its devices fall under the regulatory jurisdiction of the U.S. Food and Drug Administration (FDA). Since the company’s products are classified as Class II medical devices, they undergo specific FDA pathways for authorization, including 510(k) premarket notifications and compliance with the Unique Device Identification (UDI) system. This classification reflects a moderate level of risk, requiring post-market surveillance but not pre-market approval.

Inspirix, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identification (UDI) system. These registries are used to track and authorize medical devices in the U.S. The 510(k) pathway demonstrates that the company’s valved holding chambers are substantially equivalent to legally marketed predicate devices, while the UDI system ensures traceability and transparency in the supply chain for Class II devices like theirs.

Inspirix, Inc.’s valved holding chambers are classified as Class II medical devices in the U.S. This classification is based on the FDA’s risk assessment, where these devices are deemed to present a moderate risk to patients. As a result, they require compliance with special controls—such as performance standards, labeling requirements, and post-market surveillance—but do not require the stringent pre-market approval process reserved for higher-risk Class III devices. The classification also means they are subject to mandatory registration in the FDA’s databases.