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Pump Alignment Syringe

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220184

by Jiangsu Caina Medical Co., Ltd

Identifiers

510(k) Number
K220184 FDA 510(k)
FDA Product Code
FMF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pump Alignment Syringe is a medical device classified under the nomenclature for syringes designed to facilitate precise alignment and delivery of fluids in medical infusion systems. It is engineered to ensure accurate connection and attachment to infusion pumps, reducing the risk of misalignment during use.

This device is supplied as a single-use item and is intended for use in general hospital settings. It is not sterilised by the manufacturer but must be handled under aseptic conditions prior to use. The device is authorised under FDA 510K clearance, MDD, and MDR compliance, with a product code of FMF. No MRI safety information is specified.

Frequently asked questions

What is the Pump Alignment Syringe designed to improve during fluid delivery in medical settings?

The Pump Alignment Syringe is specifically engineered to ensure precise alignment and attachment to infusion pumps. This design reduces the risk of misalignment during use, which can help prevent errors in fluid delivery and improve the overall reliability of infusion systems in hospital environments.

Is the Pump Alignment Syringe intended for reuse, or is it meant to be used only once?

The Pump Alignment Syringe is supplied as a single-use item, meaning it should not be reused after one application. While it is not sterilized by the manufacturer, it must be handled under aseptic conditions before use to maintain sterility and patient safety.

How should I store the Pump Alignment Syringe before use, and are there any special handling requirements?

The device must be stored and handled under aseptic conditions prior to use, as it is not pre-sterilized by the manufacturer. While specific storage temperature or shelf-life details are not provided, standard medical device storage practices—such as keeping it in a clean, dry environment and avoiding contamination—should be followed.

What regulatory pathways has the Pump Alignment Syringe undergone, and what does that mean for its use?

The Pump Alignment Syringe has been authorized through FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) compliance. This means it has been evaluated for safety and performance under these regulatory frameworks, ensuring it meets applicable standards for use in general hospital settings as a single-use infusion accessory.

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

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Jiangsu Caina Medical Co., Ltd
FDA Applicant
Jiangsu Caina Medical Co.,Ltd

Sources (2)

  • FDA 510(k) K220184 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026