FDA Product Code MRZ: Accessories, Pump, Infusion
Leading manufacturers include Alexander Mfg. Co., Welldoc, Inc. and Roche Diagnostics Corp..
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
Dec 06, 2016
Hospira Sapphire Sets
Hospira, Inc.
General Hospital
288d
Cleared
Dec 16, 2013
ONETOUCH REVEAL
Lifescan, Inc.
General Hospital
117d
Cleared
May 15, 2008
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
Roche Diagnostics Corp.
General Hospital
106d
Cleared
Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P
Alexander Mfg. Co.
General Hospital
87d
Cleared
Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
Alexander Mfg. Co.
General Hospital
87d
Cleared
Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224
Alexander Mfg. Co.
General Hospital
29d
Cleared
May 27, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7)
Alexander Mfg. Co.
General Hospital
84d
Cleared
May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018
Alexander Mfg. Co.
General Hospital
55d
Cleared
May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P
Alexander Mfg. Co.
General Hospital
55d
Cleared
May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825
Alexander Mfg. Co.
General Hospital
55d
Cleared
May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108
Alexander Mfg. Co.
General Hospital
55d
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.