Keranetics, LLC

Keranetics, LLC specializes in non-antimicrobial wound care products. Their portfolio includes two primary categories: skin semi-occlusive dressings (like topical creams) and wound hydrogel dressings (like gels). These products are designed to create a moist healing environment for skin and wounds without incorporating antimicrobial agents.

Keranetics, LLC is headquartered in the United States. The company’s location is relevant for regulatory purposes, as it influences compliance with U.S. medical device regulations and reporting requirements.

Keranetics, LLC’s devices fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness. Class II devices are authorised through pathways like the 510(k) premarket notification process, which demonstrates substantial equivalence to a legally marketed predicate device.

Yes, Keranetics, LLC’s devices are included in the FDA’s 510(k) and Unique Device Identification (UDI) databases. Listing in these registries confirms their regulatory status and compliance with U.S. requirements, including mandatory identification and traceability of medical devices. This helps healthcare providers and regulators track and verify the devices’ authorised status.

Keranetics, LLC’s products are non-antimicrobial, meaning they do not contain agents like antibiotics or antiseptics to fight bacteria. Instead, they focus on maintaining a moist wound environment to support natural healing processes. This distinction is important for clinicians selecting treatments based on infection risk, as antimicrobial dressings are reserved for wounds with active infections, while Keranetics’ products are intended for general wound management.