LZG · Class II · 21 CFR 880.5725

FDA Product Code LZG: Pump, Infusion, Insulin

Insulin pump therapy enables flexible, physiological insulin delivery. FDA product code LZG covers insulin infusion pumps used by people with diabetes.

These devices deliver continuous subcutaneous insulin infusion via a programmable pump connected to a small catheter, providing basal insulin delivery and enabling mealtime bolus doses. They more closely mimic physiological insulin secretion than multiple daily injections.

LZG devices are Class II medical devices, regulated under 21 CFR 880.5725 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Medtronic Minimed, Insulet Corporation and Animas Corp..

85
Total
85
Cleared
133d
Avg days
1989
Since
85 devices
49–72 of 85
Cleared May 09, 2005
AMIGO INSULIN PUMP
K050312
Nipro Diabetes Systems, Inc.
General Hospital · 90d
Cleared Mar 18, 2005
ACCU-CHEK SPIRIT
K042887
Disetronic Medical Systems AG
General Hospital · 150d
Cleared Jan 03, 2005
IXL-II DIABETES MANAGEMENT SYSTEM
K042792
Insulet Corporation
General Hospital · 89d
Cleared Dec 10, 2004
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
K042873
Animas Corp.
General Hospital · 53d
Cleared Dec 01, 2004
MODIFICATION TO D-TRONPLUS
K043000
Disetronic Medical Systems AG
General Hospital · 30d
Cleared Jul 19, 2004
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
K041317
Medtronic Minimed
General Hospital · 62d
Cleared Jul 19, 2004
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
K041318
Medtronic Minimed
General Hospital · 62d
Cleared May 27, 2004
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
K031738
Smiths Medical MD, Inc.
General Hospital · 358d
Cleared May 21, 2004
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
K040676
Medtronic Minimed
General Hospital · 67d
Cleared Dec 19, 2003
IXL DIABETES MANAGEMENT SYSTEM
K031373
Insulet Corp.
General Hospital · 233d
Cleared Nov 18, 2003
PARADIGMPAL, MODEL MMT-7330
K031541
Minimed, Inc.
General Hospital · 186d
Cleared Oct 23, 2003
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164
Medtronic Minimed
General Hospital · 100d
Cleared Oct 16, 2003
MODEL IR 1200 INSULIN PUMP
K032257
Animas Corp.
General Hospital · 86d
Cleared Jun 17, 2003
MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
K030531
Minimed, Inc.
General Hospital · 118d
Cleared Jun 05, 2003
EZMANAGER PLUS
K022394
Animas Corp.
General Hospital · 317d
Cleared Oct 29, 2002
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
K023471
Disetronic Medical Systems AG
General Hospital · 14d
Cleared Sep 11, 2002
MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
K022831
Disetronic Medical Systems AG
General Hospital · 16d
Cleared Aug 13, 2002
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
K020655
Deltec, Inc.
General Hospital · 165d
Cleared Aug 02, 2002
DISETRONIC D-TRON INSULIN INFUSION PUMP
K021725
Disetronic Medical Systems AG
General Hospital · 70d
Cleared Aug 02, 2002
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
K022317
Sooil Development Co., Ltd.
General Hospital · 16d
Cleared Jun 24, 2002
GLUCOPRO EVO INFUSION PUMP
K013309
Nipro Diabetes Systems, Inc.
General Hospital · 263d
Cleared May 29, 2002
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
K021439
Animas Corp.
General Hospital · 23d
Cleared Dec 12, 2001
MICROJET QUARK, MODEL U100 OR U40
K013807
Cane S.R.L.
General Hospital · 27d
Cleared Aug 14, 2000
DANA DIABECARE
K001604
Sooil Development Co., Ltd.
General Hospital · 82d