Product Classification

• Device: port, protector/cushion
• Regulation Description: Subcutaneous, implanted, intravascular infusion port and catheter.
• Definition: Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.
• Physical State: Device is a foam ring with adhesive that is placed on intact skin over the port access site. The foam ring can be any defined shape that covers the port. The foam provides a barrier to the implanted port.
• Technical Method: Device is applied on top of intact skin and provides a protection barrier over the implanted port.
• Target Area: The device is used on intact skin.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: OBK
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5965
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-273 ISO 23908 First edition 2011-06-11
  Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• 6-507 ISO 23908 Second Edition 2024-12
  Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods

Third Party Review

Not Third Party Eligible