Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, has received a second 510(k) clearance (K181895) for its new Kurin® PIV18 peripheral IV configuration with an extension set, which can be used for infusion.
“We are pleased to receive clearance from the FDA, the governing body for the medical products and processes we have developed,” said Bob Rogers, CEO of Kurin. “Our Kurin PIV18 product was developed at the request of our customers, who, after using the single-use Kurin Lock® for blood culture collection, wanted to expand their use to include draws from infusion lines.”
The majority of blood cultures are taken via direct venipuncture, but there are times in busy Emergency Departments when a culture is taken from a freshly placed IV. By adding an extension set to the previously-available PIV product, nurses can leave the set in the vein after the culture is taken, saving time and sparing the patient another needlestick.
Kurin developed initial specimen diversion technology that automatically and passively diverts potential contaminants during blood culture collection. When skin microbes enter into blood culture samples, false positive test results may misinform physicians and lead to unnecessary medical treatment and risk for patients, as well as significant costs for the hospital. Kurin’s patented automatic blood diversion product is the only FDA 510k cleared blood culture diversion product on the market.
About Kurin, Inc.
Kurin Corporation, a certified Minority Business Enterprise (MBE), is focused on the design, development, manufacture, marketing, and sale of products that help healthcare providers reduce contaminated blood cultures. San Diego-based Kurin has received FDA 510(k) market clearance. For more information, visit the website at www.kurin.com.