Identifiers
- 510(k) Number
- K210217 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 Needleless Connector is a medical device classified as a needleless injection port (FDA Product Code: FPA). It provides a secure, puncture-free interface for administering intravenous fluids, medications, or blood products without the need for traditional needle insertion, thereby reducing the risk of needle-stick injuries and contamination.
This device is designed for single-use in hospital settings, including general medical wards, and is intended for sterile connection of intravenous lines to patient access ports or other infusion systems. Supplied in sterile packaging, it complies with FDA 510(k) clearance under the Traditional pathway (K210217) and adheres to EU Medical Device Regulations (MDR and MDD). No MRI safety information or reusable variants are specified.
Frequently asked questions
What is the purpose of the Needleless Connector?
The Needleless Connector provides a secure, puncture-free interface for administering intravenous fluids, medications, or blood products without traditional needle insertion, reducing needle-stick injuries and contamination risks.
Is the Needleless Connector reusable or single-use?
The Needleless Connector is designed for single-use in hospital settings, including general medical wards, and is supplied in sterile packaging.
What regulatory approvals does the Needleless Connector have?
The device has FDA 510(k) clearance under the Traditional pathway (K210217) and complies with EU Medical Device Regulations (MDR and MDD).
How is the Needleless Connector supplied?
The device is supplied in sterile packaging and is intended for sterile connection of intravenous lines to patient access ports or other infusion systems.
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
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210217 | Class II | Active |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd
- FDA Applicant
- Jiangsu Caina Medical Co.,Ltd
Sources (2)
- FDA 510(k) K210217 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 29, 2026