Lineus Medical Granted FDA 510(k) Clearance for SafeBreak®

FAYETTEVILLE, Ark. – June 1, 2021 – PRLog — The US Food and Drug Administration has cleared for sale Lineus Medical’s first medical device, SafeBreak Vascular, that reduces mechanical complications requiring IV restarts in peripheral IV lines when excessive tension (greater than 4 lbs. of force) is placed on the IV line. Tugs or pulls on IV lines are a common occurrence and part of every patient’s time in the hospital. The current method for securing IV catheters includes the use of adhesive dressings and securement devices. All current methods focus on securing the line to the patient’s skin and these solutions fail when the IV tubing is subjected to large pull forces. SafeBreak Vascular works differently than current methods and is part of a new class of devices called Force-Activated Separation Devices. Force-Activated Separation Devices separate to remove the damaging force from the IV line and prevent the loss of blood and medication.

SafeBreak Vascular is the first ever Force-Activated Separation Device cleared to be sold in the United States through the FDA’s De Novo review process. Upon separation, a valve in each end of SafeBreak closes. On the patient side, the IV is left intact and the valve closes and prevents the patient from bleeding. On the IV pump side, the valve closes and stops the pump from pumping medicine onto the floor or in the patient’s bed. When the fluid flow from the IV pump is stopped, it causes the pump to alarm, letting the medical team know they need to address the situation. The separated SafeBreak Vascular can be discarded and a new one installed in the line in only a few minutes. The patient’s medical treatment can resume by restarting the IV infusion without the need for a new catheter or additional needle sticks.