Port Caps (protective Closures Foe Reprocessed Hemodialyzers
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K950602 FDA 510(k)
- FDA Product Code
- FJI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Port Caps are protective closures designed for use on reprocessed hollow-fiber capillary hemodialyzers. These devices serve as sterile barriers to prevent contamination and maintain the integrity of the dialyzer ports during storage, transport, and reprocessing, ensuring safe reuse in hemodialysis procedures.
Port Caps are supplied as single-use, non-sterile components intended for application on reprocessed hemodialyzers in clinical or reprocessing facility settings. They comply with FDA 510(k) clearance (K950602) under product code FJI and regulation 21 CFR 876.5820, classified as a Class II device. Each cap is engineered to fit standard hemodialyzer ports, ensuring a secure seal without compromising functionality.
Frequently asked questions
What are Port Caps used for in hemodialysis?
Port Caps are protective closures designed to seal the ports of reprocessed hollow-fiber capillary hemodialyzers. They act as sterile barriers to prevent contamination during storage, transport, and reprocessing, ensuring the dialyzer remains safe for reuse in hemodialysis procedures. This helps maintain the integrity of the device between uses, reducing the risk of infection or cross-contamination.
Are Port Caps sterile and single-use?
Port Caps are supplied as single-use components but are not sterile at the time of shipment. They are intended to be applied to reprocessed hemodialyzers in clinical or reprocessing facility settings, where they provide a sterile seal when properly used. Sterility is achieved through the application process in a controlled environment, not through the packaging of the caps themselves.
How do I determine the correct size or model of Port Caps for my hemodialyzers?
Port Caps are engineered to fit standard hemodialyzer ports, meaning they are designed for universal compatibility with most reprocessed hollow-fiber capillary hemodialyzers. No additional sizing is required—each cap is pre-sized to create a secure seal without compromising the dialyzer’s functionality. Always verify compatibility with your specific hemodialyzer model before use, as variations in port design may exist.
Where should Port Caps be stored before use?
Port Caps should be stored in a clean, dry, and dust-free environment to prevent contamination before application. Avoid exposure to direct sunlight, extreme temperatures, or moisture, as these conditions could degrade the material or compromise sterility. Store them in their original packaging until ready for use, and ensure the facility adheres to standard reprocessing protocols for handling single-use accessories.
What regulatory approvals apply to Port Caps?
Port Caps hold FDA 510(k) clearance (K950602) under product code FJI and regulation 21 CFR 876.5820, classifying them as a Class II medical device. This clearance confirms they are substantially equivalent to a legally marketed predicate device and meet U.S. safety and performance standards. The device is also associated with the Gastroenterology and Urology advisory committees, reflecting its role in supporting hemodialysis procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Port Caps (Protective Closures Foe Reprocessed Hemodialyzers, 510 (k) Premarket Notification - Food and Drug Administration, PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS 510(k ..., Port Caps (Protective Closures Foe Reprocessed Hemodialyzers, PDF Port Caps for Reprocessed Dialyzers
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950602 | Class II | Active |
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Manufacturer
- Manufacturer
- Reprocessing Products Corp
Sources (1)
- FDA 510(k) K950602 24 fields · synced Oct 5, 2026