FDA Product Code MRZ: Accessories, Pump, Infusion
Leading manufacturers include Welldoc, Inc., Roche Diagnostics Corp. and B.Braun Medical, Inc..
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
Cleared
Mar 26, 2021
RG 3ml Medication Cartridge
Chengdu Shifeng Medical Technology Co., Ltd.
General Hospital
283d
Cleared
Apr 07, 2020
BlueStar Rx
Welldoc, Inc.
Chemistry
99d
Cleared
Mar 12, 2020
SpaceStation MRI
B. Braun Melsugen AG
General Hospital
239d
Cleared
Nov 04, 2019
WellDoc BlueStar
Welldoc, Inc.
General Hospital
305d
Cleared
Aug 02, 2018
Lockbox for Perfusor Space PCA Infusion Pump
B.Braun Medical, Inc.
General Hospital
260d
Cleared
May 15, 2008
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
Roche Diagnostics Corp.
General Hospital
106d
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.