FDA 510(k) General Hospital Devices

FDA 510(k) General Hospital Devices - Regulatory Overview

FDA 510(k) general hospital devices cover a broad range of equipment used across hospital departments. The FDA review panel code is HO.

This is one of the largest 510(k) categories, with 17,707 submissions since 1976. It includes:

• Infusion and delivery systems - IV pumps, syringe drivers, enteral feeding
• Vascular access devices - IV catheters, PICC lines, ports
• Hospital beds and patient handling - adjustable beds, transfer devices
• Sterilization and disinfection - autoclaves, chemical disinfectants, endoscope reprocessors
• Wound care - negative pressure wound therapy, dressings