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Iv Decanter-Flexible

FDA 510(k)

Class II (US FDA 510(k))

510(k) K980587

by Inrad

Identifiers

510(k) Number
K980587 FDA 510(k)
FDA Product Code
LHI 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 Iv Decanter-Flexible is a fluid transfer device that consists of a flexible tube with an integrated spike at one end for connection to a flexible fluid container and a clamp to control fluid flow. It is designed for use in intravenous (IV) applications to decant fluids safely and efficiently.

The device is classified as a Class 2 General Hospital device with product code LHI and has received FDA 510(k) clearance (K980587) via the traditional pathway. It is manufactured by Inrad in Kentwood, Michigan, United States, and is listed under the FDA’s decision of substantially equivalent.

Frequently asked questions

What is the IV Decanter-Flexible used for?

It is intended for intravenous (IV) applications to decant fluids safely and efficiently. The flexible tube and integrated spike connect to a fluid container, while the clamp controls flow, allowing clinicians to transfer fluids without spillage or contamination.

How is the device supplied and what are its components?

The device is supplied as a single unit comprising a flexible tube, an integrated spike at one end for attachment to a fluid container, and a clamp to regulate flow. All components are pre‑assembled, so no additional assembly is required before use.

Is the IV Decanter-Flexible sterile and single‑use?

The product description does not specify sterility or single‑use status, so users should refer to the packaging or manufacturer’s labeling for those details. Typically, fluid transfer devices for IV use are supplied sterile and intended for single‑patient use to maintain safety.

What regulatory pathway did the IV Decanter-Flexible follow?

It received FDA 510(k) clearance (K980587) via the traditional pathway, meaning the device was found substantially equivalent to a legally marketed predicate. This classification places it in Class 2 under product code LHI for general hospital devices.

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: IV DECANTER-FLEXIBLE (K980587) — FDA 510 (k) | Innolitics, K980587 FDA 510 (k) - IV DECANTER-FLEXIBLE | Inrad, Iv Decanter-flexible 510 (k) FDA Premarket Notification K980587 INRAD, Iv Decanter-flexible - Beudamed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Inrad

Sources (1)

  • FDA 510(k) K980587 24 fields · synced Sep 23, 2026