FDA Product Code QNS: Low Dead Space Needle, Single Lumen, Hypodermic
A Low Dead Space Single Lumen Hypodermic Needle Is A Device Designed To Reduce Medication Waste. The Device Consists Of A Metal Tube That Is Sharpened At One End And At The Other End Joined To Connector Designed To Mate With A Piston Syringe. It May Or May Not Have Needle Safety Features. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient.
Leading manufacturers include Ocuject, LLC, Poonglim Pharmatech, Inc. and Tsk Laboratory International Japan KK.
FDA 510(k) Cleared Low Dead Space Needle, Single Lumen, Hypodermic Devices (Product Code QNS)
About Product Code QNS - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QNS since 2021, with 3 receiving FDA clearance (average review time: 99 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QNS have taken an average of 30 days to reach a decision - down from 268 days historically, suggesting improved FDA processing for this classification.
QNS devices are reviewed by the General Hospital panel. Browse all General Hospital devices →