FDA Product Code QOI: Intravenous Catheter Force-activated Separation Device.
An Intravenous (iv) Catheter Force-activated Separation Device. An Intravenous Catheter Force-activated Separation Device Is Placed Inline With An Intravenous Catheter And An Intravascular Administration Set, Including Any Administration Set Accessories. It Separates Into Two Parts When A Specified Force Is Applied. The Device Is Intended To Reduce The Risk Of Iv Catheter Failure(s) Requiring Iv Catheter Replacement.
Leading manufacturers include Linear Health Sciences, LLC, Lineus Medical and Site Saver, Inc. D/B/A Lineus Medical.
FDA 510(k) Cleared Intravenous Catheter Force-activated Separation Device. Devices (Product Code QOI)
About Product Code QOI - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code QOI since 2021, with 7 receiving FDA clearance (average review time: 188 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under QOI have taken an average of 112 days to reach a decision - down from 199 days historically, suggesting improved FDA processing for this classification.
QOI devices are reviewed by the General Hospital panel. Browse all General Hospital devices →