Apnicure, Inc.

Apnicure, Inc. produces a range of reusable and single-use medical devices, including breathing mouthpieces for medical applications, line-powered suction systems for clinical settings, dental wax impression materials, and electrical-only connection cables designed for compatibility with medical devices. They also offer software applications for physician-practice management, which streamline administrative workflows in healthcare environments.

Apnicure, Inc. is headquartered in the United States, which means its devices are subject to FDA regulatory requirements. Since the company’s products fall under Class II classification—considered moderate risk—they must comply with FDA pathways like 510(k) clearances or De Novo submissions to demonstrate safety and effectiveness before entering the market.

Apnicure’s devices are registered in the FDA’s official device databases, including the 510(k) Premarket Notification database and the Unique Device Identifier (UDI) system. These registries track authorised medical devices in the U.S. to ensure transparency and compliance with regulatory requirements.

All of Apnicure’s listed devices are classified as Class II under the FDA’s regulatory framework. This classification applies to products that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness before and after market authorisation.

The FDA uses 510(k) clearances for devices that are substantially equivalent to legally marketed predecessors, demonstrating they meet the same safety and performance standards. De Novo submissions are used for novel devices with no predicate, requiring the FDA to classify them as Class I or II and establish regulatory controls. Both pathways ensure devices meet regulatory requirements before commercialisation.