FDA Product Code MRZ: Accessories, Pump, Infusion
Leading manufacturers include Elite Biomedical Solutions and Gilero, LLC.
48
Total
48
Cleared
131d
Avg days
1997
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Accessories, Pump, Infusion Devices (Product Code MRZ)
48 devices
Cleared
Jun 15, 2023
UTC 3mL Medication Cartridge
Gilero, LLC
General Hospital
92d
Cleared
Apr 29, 2022
Elite Biomedical Solutions Dose Request Cord
Elite Biomedical Solutions
General Hospital
51d
About Product Code MRZ - Regulatory Context
510(k) Submission Activity
48 total 510(k) submissions under product code MRZ since 1997, with 48 receiving FDA clearance (average review time: 131 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
MRZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →