Kurin, Inc. receives FDA 510k clearance for its push-button needle
Kurin Inc., the inventor and manufacturer of 510(k)-cleared Kurin® blood culture collection sets, has received 510(k) clearance (k191832) for its novel push-button needle.
“The FDA clearance of our push-button needle is another important step in the continued growth of our company,” said Bob Rogers, CEO of Kurin. “Development of our proprietary needle provides us vertical integration and also allows us to offer superior options to our customers. We are experiencing exponential growth and milestones like this one position Kurin well for our rapid expansion plans,” said Mr. Rogers.
Kurin developed initial specimen discard technology that automatically and passively sidelines 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 discard product is the only FDA 510(k) cleared blood culture product in its class.
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.