One-Link Needle-Free IV Connector and Extension Sets

• • Terminated Z-1102-2021 FDA Class II ·initiated 21 Dec 2020

  There were customer reports of separation between the tubing and Male Luer Lock Adaptor.

• • Terminated Z-0132-2016 FDA Class II ·initiated 21 May 2015

  Potential for a leak at the tubing to luer bond.

Full name

Neutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension Sets

510(k) Number

K132734 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the One-Link Needle-Free IV Connector and Extension Sets, and how does it improve patient safety?

  The One-Link Needle-Free IV Connector and Extension Sets are designed to provide a secure, needle-free connection for administering intravenous fluids, medications, or solutions to patients. They eliminate the need for traditional needle connections, which significantly reduces the risk of needle-stick injuries and microbial contamination during use. This design ensures a safer administration process while maintaining compatibility with standard male Luer adapters.

• Are these devices intended for reuse or single-patient use, and why?

  These devices are explicitly designed for single-patient use with vascular access devices. The manufacturer emphasizes sterility and single-use to minimize contamination risks and ensure patient safety, aligning with best practices for intravenous administration systems.

• What length and configuration are the extension sets available in, and how does this affect their use?

  The extension sets come in a standard bore configuration with a fixed length of 7.6 inches (19.3 cm). This length is optimized for flexibility in hospital settings, allowing for easy integration with existing IV lines while maintaining a practical reach for healthcare providers during fluid or medication administration.

• How are these devices supplied, and what does that mean for storage and handling?

  The One-Link Needle-Free IV Connector and Extension Sets are supplied as sterile, single-use items. This means they must be stored in their original packaging until use to preserve sterility, and each device can only be used once per patient. Proper storage ensures contamination prevention and compliance with medical device handling protocols.

• What regulatory pathway was followed for FDA clearance, and what does that indicate about the device’s classification?

  The device was cleared via an FDA 510(k) pathway under the General Hospital advisory committee (HO), with a classification as a needle-free injection port and catheter extension set. The clearance type is labeled as *Special*, and the product code (FPA) reflects its categorization under the General Hospital advisory committee, indicating it meets FDA standards for safety and effectiveness in hospital environments.