MACLIN POWER, INC.

Maclin Power, Inc. specializes in intravenous administration tubing extension sets. These devices are designed to connect infusion pumps or other fluid delivery systems to patient intravenous lines, ensuring safe and controlled fluid administration. The primary focus is on maintaining sterile connections and reliable fluid flow during medical procedures.

Maclin Power, Inc. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Since the company operates within the U.S., its products must comply with FDA regulations, including classification, clearance, and listing requirements like the 510(k) pathway and UDI system.

Maclin Power, Inc.’s intravenous tubing extension sets are classified as Class II devices by the FDA. This classification indicates that they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II devices typically require pre-market notification (510(k)) clearance, which demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with regulatory standards.

Maclin Power, Inc.’s devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. The 510(k) clearance process confirms regulatory compliance, while the UDI system provides a standardized identification system for tracking devices throughout their lifecycle, improving transparency and traceability in healthcare settings.

The repeated listing of the BIOSITE/BIOSITE PLUS model reflects variations or iterations of the same core device design, which may include updates in materials, features, or manufacturing processes. While the name remains consistent, each iteration must still comply with FDA requirements, such as 510(k) clearance, to ensure continued safety and performance. The FDA tracks these updates to maintain accurate records of authorized devices.