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

Pump, Infusion, Enteral

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

LZH is the FDA product code for Pump, Infusion, Enteral, a class II device type, regulated under 21 CFR 880.5725. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 24 recalls.

Classification record

Product code
LZH
Device name
Pump, Infusion, Enteral
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
34
Ingested recalls
24

Clearances, product code LZH

By decision year
34 clearances under product code LZH with a decision year between 1987 and 2026, 1995 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LZH by decision year
YearClearances
19871
19891
19901
19911
19922
19931
19942
19954
19962
19981
20013
20032
20042
20061
20121
20142
20151
20161
20201
20222
20231
20261

Applicants with the most clearances

Product code LZH
Applicants holding the most 510(k) clearances under product code LZH
ApplicantClearances
Medtronic, Inc.4
Sandoz Nutrition3
Amsino International, Inc.2
Frantz Medical Development, Ltd.2
Ross Product Div. Abbott Laboratories2
Sherwood Medical Co.2
Zevex Intl., Inc.2
Abbott Medical1
Abbott Mfg., Inc.1
Acacia, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order