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 and Development, DEKA Research & Development and Deka Research & Development Corp..
4
Total
4
Cleared
138d
Avg days
2020
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
29d
recently vs 174d historically
FDA 510(k) Cleared Infusion Pump, Drug Specific, Pharmacy-filled Devices (Product Code QJY)
4 devices
Cleared
Nov 27, 2024
Remunity System
Deka Research & Development Corp.
General Hospital
29d
Cleared
Jun 12, 2024
Remunity System
Deka Research and Development
General Hospital
133d
Cleared
Dec 30, 2020
Remunity Pump for Remodulin (treprostinil) Injection
Deka Research and Development
General Hospital
106d
Cleared
Feb 21, 2020
Unity Subcutaneous Infusion System for Remodulin
DEKA Research & Development
General Hospital
282d
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 remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - QJY Product Code
Recent submissions under QJY have taken an average of 29 days to reach a decision - down from 174 days historically, suggesting improved FDA processing for this classification.
QJY devices are reviewed by the General Hospital panel. Browse all General Hospital devices →