MRZ · Class II · 21 CFR 880.5725

FDA Product Code MRZ: Accessories, Pump, Infusion

Leading manufacturers include Alexander Mfg. Co., Welldoc, Inc. and National Custom Ent., 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
1–24 of 48
Cleared Jun 15, 2023
UTC 3mL Medication Cartridge
K230718
Gilero, LLC
General Hospital · 92d
Cleared Apr 29, 2022
Elite Biomedical Solutions Dose Request Cord
K220695
Elite Biomedical Solutions
General Hospital · 51d
Cleared Mar 26, 2021
RG 3ml Medication Cartridge
K201634
Chengdu Shifeng Medical Technology Co., Ltd.
General Hospital · 283d
Cleared Apr 07, 2020
BlueStar Rx
K193654
Welldoc, Inc.
Chemistry · 99d
Cleared Mar 12, 2020
SpaceStation MRI
K191910
B. Braun Melsugen AG
General Hospital · 239d
Cleared Nov 04, 2019
WellDoc BlueStar
K190013
Welldoc, Inc.
General Hospital · 305d
Cleared Aug 02, 2018
Lockbox for Perfusor Space PCA Infusion Pump
K173531
B.Braun Medical, Inc.
General Hospital · 260d
Cleared Aug 25, 2017
Sapphire Sets
K171346
Icu Medical
General Hospital · 109d
Cleared Jan 12, 2017
WellDoc BlueStar, WellDoc BlueStar Rx
K162532
Welldoc, Inc.
General Hospital · 125d
Cleared Dec 06, 2016
Hospira Sapphire Sets
K160492
Hospira, Inc.
General Hospital · 288d
Cleared Nov 22, 2016
WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
K162225
Welldoc, Inc.
General Hospital · 106d
Cleared Feb 13, 2015
ivWatch Model 400
K142374
Ivwatch, LLC
General Hospital · 171d
Cleared Dec 18, 2014
SMART LABEL, PROPOFOL
K142333
American I.V. Products, Inc. Dba Aiv, Inc.
General Hospital · 119d
Cleared Jul 08, 2014
WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
K141273
Welldoc, Inc.
General Hospital · 53d
Cleared Dec 16, 2013
ONETOUCH REVEAL
K132618
Lifescan, Inc.
General Hospital · 117d
Cleared Apr 12, 2012
PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE
K120209
American I.V. Products, Inc.
General Hospital · 79d
Cleared Feb 24, 2012
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
K120314
Welldoc, Inc.
General Hospital · 23d
Cleared Oct 14, 2011
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
K112370
Welldoc, Inc.
General Hospital · 58d
Cleared Dec 07, 2010
AIDERA DIASEND SYSTEM
K101806
Aidera AB
General Hospital · 162d
Cleared Jul 15, 2010
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
K100066
Welldoc, Inc.
General Hospital · 185d
Cleared Jun 12, 2009
LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS
K091181
Smiths Medical MD, Inc.
General Hospital · 50d
Cleared Feb 03, 2009
AIDERA DIASEND
K083221
Aidera AB
General Hospital · 95d
Cleared Dec 17, 2008
CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE
K082783
Smiths Medical MD, Inc.
General Hospital · 85d
Cleared May 15, 2008
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
K080227
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.