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Flush Syringe (Prefilled 0.9% Normal Saline Solution)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K231724

by Spm Medicare Pvt. , Ltd.

Identifiers

510(k) Number
K231724 FDA 510(k)
FDA Product Code
NGT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Saline, Vascular Access Flush (per FDA nomenclature), designed as a prefilled syringe containing 0.9% normal saline solution. It is intended for flushing vascular access ports, catheters, or other intravenous lines to maintain patency and prevent occlusion by residual blood or medication.

The Flush Syringe is supplied as a single-use, sterile product, classified under FDA regulation 880.5200 and cleared via FDA 510(k) and MDR pathways. It is intended for use in general hospital settings and must be discarded after one-time use. No MRI safety information is specified, and sizes or additional storage requirements are not detailed in the provided data.

Frequently asked questions

What is the primary purpose of this Flush Syringe, and where is it typically used?

This Flush Syringe is designed to deliver 0.9% normal saline solution for flushing vascular access ports, catheters, or intravenous lines. Its purpose is to maintain patency and prevent occlusion caused by residual blood or medication, making it essential in general hospital settings for intravenous care.

Is this device intended for single-use or repeated use, and why?

This Flush Syringe is explicitly labeled as a single-use product. The manufacturer emphasizes its sterile nature and advises discarding it after one-time use to ensure patient safety and prevent contamination, which is critical for maintaining aseptic conditions in medical procedures.

What regulatory pathways has this device followed for approval, and what does that mean for its use?

The device has been cleared via the FDA’s 510(k) pathway and the EU’s MDR (Medical Device Regulation). This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device (FDA) or compliance with EU safety, performance, and clinical requirements (MDR), ensuring its suitability for use in approved medical environments.

Are there any specific storage instructions or considerations mentioned for this device?

The provided data does not specify storage requirements such as temperature or environmental conditions. However, as a sterile, single-use medical device, it should be stored in a clean, dry place away from direct sunlight and extreme temperatures to preserve its integrity until use.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spm Medicare Pvt. , Ltd.

Sources (2)

  • FDA 510(k) K231724 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026