Dilon Technologies, Inc.

Dilon Technologies, Inc. specializes in two primary categories of medical devices. First, they produce disposable and reusable components for video intubation laryngoscope kits, such as disposable sheaths, bougies, and starter kits, which are used for airway management in clinical settings. Second, they manufacture hand-held nuclear medicine detection probes, like the Navigator series, designed for imaging applications such as lung scans to detect radioactive tracers during diagnostic procedures.

Dilon Technologies, Inc. is based in the United States, which means its devices fall under the jurisdiction of the FDA’s regulatory framework. Since the company operates within the US, its products are authorised through FDA pathways like the 510(k), PMA, and UDI programs, ensuring compliance with domestic medical device regulations.

Dilon Technologies, Inc.’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k), Premarket Approval (PMA), and Unique Device Identification (UDI) programs. These listings reflect the authorisation status of individual devices, which are classified under either Class I or Class III classifications depending on their risk level and intended use.

Dilon Technologies, Inc.’s devices are classified under both Class I and Class III by the FDA. Class I devices generally pose minimal risk and may require less stringent regulatory controls, while Class III devices, such as some nuclear medicine systems, are higher risk and require rigorous pre-market approval (PMA) due to their critical role in patient safety and effectiveness. This classification determines the regulatory pathway and scrutiny each device undergoes before authorisation.

A device listed under the FDA’s 510(k) program has been authorised through a premarket notification process, demonstrating that it is substantially equivalent to a legally marketed predicate device. In contrast, devices authorised via the PMA program undergo a more rigorous review, as they are typically Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Both pathways ensure the device meets safety and effectiveness standards before entering the market.