KelCor, LLC

KelCor, LLC specializes in two primary categories of medical devices: eye patches and multi-purpose surgical skin adhesive tapes. Their products include items like the KC Eye Tape for ocular protection and the KC Airway Tape or KC Airway Taping System, which are designed for securing airway tubes and creating secure adhesive barriers during medical procedures. These devices are intended for low-risk applications, such as temporary protection or stabilization.

KelCor, LLC is based in the United States. Since its devices are classified as Class I under FDA regulations, they are subject to the U.S. regulatory framework for low-risk medical devices. The company must comply with FDA requirements for manufacturing, labeling, and listing devices in the FDA’s Unique Device Identifier (UDI) database, ensuring transparency and traceability for these products.

KelCor, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring healthcare providers and regulators can access accurate information about the products, including their classification and intended use.

KelCor, LLC’s devices are classified as Class I medical devices by the FDA. This classification applies to low-risk items like eye patches and adhesive tapes, which pose minimal potential harm to patients. Class I devices typically require less stringent regulatory oversight compared to higher-risk categories, but they still must meet basic safety and performance standards. The classification ensures that these products are subject to appropriate controls while minimizing regulatory burden without compromising patient safety.