510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LZGClass II

Pump, Infusion, Insulin

21 CFR 880.5725 / General Hospital
FDA source (opens on fda.gov)

LZG is the FDA product code for Pump, Infusion, Insulin, a class II device type, regulated under 21 CFR 880.5725. As of , FDA records hold 84 510(k) clearances under this code, the most recent dated , and 126 recalls.

Classification record

Product code
LZG
Device name
Pump, Infusion, Insulin
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
85
Ingested recalls
126

Clearances, product code LZG

By decision year
85 clearances under product code LZG with a decision year between 1989 and 2026, 2002 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code LZG by decision year
YearClearances
19891
19902
19911
19961
19973
19994
20002
20011
20027
20036
20046
20056
20063
20073
20086
20092
20102
20114
20123
20132
20144
20151
20164
20171
20181
20192
20211
20221
20231
20242
20262

Applicants with the most clearances

Product code LZG
Applicants holding the most 510(k) clearances under product code LZG
ApplicantClearances
Medtronic, Inc.15
Insulet Corporation13
Disetronic Medical Systems10
Animas Corp.7
Tandem Diabetes Care, Inc.7
Abbott Medical6
Nipro Diabetes Systems, Inc.3
Roche Diagnostics GmbH3
Sooil Development Co., Ltd.3
Asante Solutions, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order