FDA Product Code QJY: Infusion Pump, Drug Specific, Pharmacy-filled
A Pharmacy-filled, Drug Specific Infusion System Is A Prescription Device Intended For Delivery Of A Specific Drug In Accordance With The Fda Approved Labeling And May Be Filled At A Location Other Than Point Of Care.
Leading manufacturers include Deka Research & Development Corp. and Deka Research and Development.
FDA 510(k) Cleared Infusion Pump, Drug Specific, Pharmacy-filled Devices (Product Code QJY)
About Product Code QJY - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QJY since 2020, with 4 receiving FDA clearance (average review time: 138 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QJY have taken an average of 81 days to reach a decision - down from 194 days historically, suggesting improved FDA processing for this classification.
QJY devices are reviewed by the General Hospital panel. Browse all General Hospital devices →