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Extension Set, Models 1911-512

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020926

by Epimed International, Inc.

Identifiers

510(k) Number
K020926 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)

An extension set is a device intended for the conduction of fluids or medications. It is used to extend the reach of intravenous or other fluid delivery systems.

The device is supplied in a non-sterile condition and is intended for single-use. It has an internal diameter of 0.03 inches and features a phthalate-free injection fluid path suitable for high flow rates and viscous fluids. It is authorized under FDA 510(k) clearance K020926 with product code FPA.

Frequently asked questions

What is the EXTENSION SET, MODELS 1911-512 intended for?

The device is intended for the conduction of fluids or medications and is used to extend the reach of intravenous or other fluid delivery systems, as stated in its description.

How is the EXTENSION SET, MODELS 1911-512 supplied and is it sterile?

The device is supplied in a non-sterile condition and is intended for single-use, meaning it should not be reprocessed or reused after initial use.

What are the key physical and material specifications of the EXTENSION SET, MODELS 1911-512?

It has an internal diameter of 0.03 inches and features a phthalate-free injection fluid path, which is suitable for high flow rates and viscous fluids.

Under what regulatory pathway was the EXTENSION SET, MODELS 1911-512 cleared for marketing?

The device is authorized under FDA 510(k) clearance K020926, with a traditional clearance type and a substantially equivalent decision based on the product code FPA.

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: Standard Extension Set - Epimed International, EXTENSION SET, MODELS 1911-512 (K020926) — FDA 510(k) | Innolitics, EPIMED INTERNATIONAL, INC 1911-512 Epimed - RevMed, AccessGUDID - %E5%BF%85%E5%BA%94%E9%9C%B8%E5%B1%8F%E5%A4%96%E6%8E%A8%E3 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Epimed International, Inc.

Sources (1)

  • FDA 510(k) K020926 24 fields · synced Sep 19, 2026