Port-Lock
by Norfolk Medical Products, Inc.
510(k) K823845
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823845 | Date1 Mar 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Port-Lock is a vascular access port designed for subcutaneous implantation, facilitating repeated intravenous access. It provides a reservoir for medication administration, blood sampling, or parenteral nutrition while minimizing skin punctures and associated risks.
This device is supplied sterile and intended for single-use, requiring surgical implantation by a healthcare professional. It is classified under product code FPA and has received FDA 510(k) clearance (K823845) under the Traditional pathway, with a decision date of March 1, 1983. Compliance with regulatory standards ensures safe use in clinical settings.
From the manufacturer
From the first human implant of a vascular access port (VAP) in 1982, to the first omni-directional access port in 1991, to the dynamic TidalPort™ of today, Norfolk Medical has pioneered innovative, cost-effective access solutions.
The Norfolk Medical team is devoted to providing healthcare professionals and patients with high-quality products that perform reliably in accordance with customer expectations, and which meet or exceed regulatory requirements and standards. We strive to lead the industry in the design and manufacturing of innovative medical device systems.
Other devices from Norfolk Medical Products, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the Port-Lock vascular access port primarily used for in clinical settings?
The Port-Lock is designed for subcutaneous implantation to provide repeated intravenous access. It serves as a reservoir for medication administration, blood sampling, or parenteral nutrition, reducing the need for frequent skin punctures and lowering associated risks like infection or discomfort.
Is the Port-Lock intended for single-use or reusable applications?
The Port-Lock is explicitly intended for single-use only. After implantation, it is not meant to be removed and reused, as it is supplied sterile and meant to be used once by a healthcare professional during surgery.
How is the Port-Lock supplied, and what precautions should be taken during handling?
The Port-Lock is supplied sterile, meaning it is pre-sterilized to prevent contamination before use. Since it is single-use, it must be handled with sterile techniques to maintain its sterility until surgical implantation by a healthcare professional.
What regulatory pathway was followed for FDA clearance of the Port-Lock, and what does this mean for its use?
The Port-Lock received FDA clearance through the Traditional 510(k) pathway, specifically under the product code FPA (vascular access ports). This means it was determined to be substantially equivalent to a legally marketed device already on the market, ensuring it meets regulatory standards for safety and effectiveness in clinical settings.