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Nexus Pressure Rated Extension Sets

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092382

by Nexus Medical, LLC

Identifiers

510(k) Number
K092382 FDA 510(k)
FDA Product Code
FPA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Nexus Pressure-Rated Extension Sets are classified as Infusion Sets under FDA Product Code FPA. These devices are designed to connect intravenous (IV) administration systems to vascular access ports, facilitating the delivery of fluids, medications, blood, or blood products to patients. Their pressure-rated construction ensures compatibility with high-pressure infusion systems, including power injectors, while preventing unintended blood reflux through advanced anti-reflux technology. The sets incorporate needleless connectors to enhance safety and usability in clinical settings.

These extension sets are supplied as single-use, sterile medical devices, intended for use in hospital and healthcare facility environments where infusion therapy is administered. They are available in various lengths, including the 6" Microbore Pressure-Rated Extension Set (e.g., N4685MN-B), and must be stored under controlled conditions to maintain sterility. The devices comply with FDA 510(k) clearance (K092382) under the Traditional 510(k) review pathway, with no third-party involvement. Compatibility with power injectors up to 325 psi is explicitly stated in the specifications.

Frequently asked questions

What are the Nexus Pressure-Rated Extension Sets designed for?

These extension sets are specifically engineered to connect intravenous administration systems to vascular access ports. They enable the delivery of fluids, medications, blood, or blood products while ensuring compatibility with high-pressure infusion systems, such as power injectors. The pressure-rated design prevents unintended blood reflux, enhancing safety during infusion therapy.

Are the Nexus Pressure-Rated Extension Sets single-use or reusable?

The Nexus Pressure-Rated Extension Sets are intended for single-use only. This design choice ensures patient safety by eliminating the risk of contamination or cross-infection that could arise from reuse. Each set is supplied sterile and must be discarded after one use.

What lengths are available for the Nexus Pressure-Rated Extension Sets?

The Nexus Pressure-Rated Extension Sets come in various lengths, including the 6" Microbore Pressure-Rated Extension Set, such as the model N4685MN-B. These lengths are designed to accommodate different clinical setups and patient needs, ensuring flexibility in intravenous therapy applications.

How should these extension sets be stored to maintain sterility?

To preserve sterility, these extension sets must be stored under controlled conditions as specified by the manufacturer. This typically includes keeping them in their original, sealed packaging away from direct sunlight, moisture, and extreme temperatures. Proper storage ensures the integrity of the sterile barrier until use.

What is the regulatory pathway for the Nexus Pressure-Rated Extension Sets?

The Nexus Pressure-Rated Extension Sets have received FDA 510(k) clearance (K092382) under the Traditional 510(k) review pathway. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and complies with applicable regulations for infusion sets under product code FPA. No third-party involvement was required for this clearance.

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: Nexus Medical Catalog, N4685MN-B landing page - Nexus Medical, fda.innolitics.com, K092382 FDA 510 (k) - NEXUS PRESSURE RATED EXTENSION SETS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nexus Medical, LLC

Sources (1)

  • FDA 510(k) K092382 24 fields · synced Oct 5, 2026