The first slide-activated safety peripheral IV catheter with an integrated extension set to receive FDA 510(k) clearance
CHANHASSEN, MN, UNITED STATES, August 18, 2026 /EINPresswire.com/ — MedSource Labs today announced the launch of the ClearSafe Comfort® Closed System, the first slide-activated safety peripheral IV catheter (PIVC) with an integrated extension set to receive FDA 510(k) clearance.
Todd Fagley, Founder and CEO of MedSource Labs, said, “An estimated 350 million PIVCs are used in the United States each year. With the ClearSafe Comfort Closed System, we offer meaningful innovation to this sizable market—we’ve combined many of the features from the catheters we’ve been making for decades into an integrated, all-in-one device.”
Features of the ClearSafe Comfort Closed System include:
Patient and clinician safety
• The needle retracts securely with a smooth sliding motion until it’s fully enclosed and locked, helping prevent accidental needlestick injuries
• Needle-free connectors support aseptic medication and fluid administration without a needle puncture in the port
• Integrated blood control helps reduce exposure to contamination and infection risk
Fewer IV starts and less waste
• Superior needle sharpness improves first-stick success, reducing waste from multiple attempts and minimizing patient discomfort
• Increased dwell times diminish the need to replace catheters as often during a patient’s hospital stay
• By combining the IV catheter with the extension set, clinicians save time with opening and connecting multiple packages and components
Enhanced patient comfort
• Sharp needles pierce the skin with less force
• Biocompatible polyurethane catheter material softens in the vein
• Smooth, stabilizing wings rest on the patient’s skin to reduce movement or jostling of the catheter once in place
• Port offset from the catheter helps prevent dislodgement during fluid or medication administration
The ClearSafe Comfort Closed System builds on two decades of expertise in vascular access design and manufacturing. Through its vertically integrated supply chain, MedSource Labs is well-positioned to deliver consistent quality and stock, shipping millions of PIVCs worldwide annually.
“With this product launch, MedSource Labs now offers every style, gauge, and configuration of peripheral IV catheter available in the United States—giving hospitals, clinics, and EMS providers a PIVC to match the needs of nearly every setting, patient, or situation, with no retraining required,” said Dave Kunelius, President of MedSource Labs.
For more information on the ClearSafe Comfort Closed System, visit https://medsourcelabs.com/clearsafe-comfort-closed-system.
About MedSource Labs: MedSource Labs is a leading medical device provider specializing in high-quality Class II medical products with a focus on IV therapy and respiratory care. Since 2002, MedSource Labs has been dedicated to enhancing patient outcomes through innovation, exceptional service, strategic global manufacturing relationships, and a commitment to compliance and quality.
Jeremy Belloit
MedSource Labs
jbelloit@medsourcelabs.com
ClearSafe Comfort Closed System
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