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

Injector, Fluid, Non-Electrically Powered

21 CFR 880.5430 / General Hospital
FDA source (opens on fda.gov)

KZE is the FDA product code for Injector, Fluid, Non-Electrically Powered, a class II device type, regulated under 21 CFR 880.5430. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KZE
Device name
Injector, Fluid, Non-Electrically Powered
Regulation
21 CFR 880.5430
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
53
Ingested recalls
1

Clearances, product code KZE

By decision year
53 clearances under product code KZE with a decision year between 1977 and 2012, 1985 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KZE by decision year
YearClearances
19771
19843
19855
19861
19874
19881
19891
19901
19912
19922
19941
19952
19963
19972
19981
19991
20001
20014
20023
20031
20043
20052
20061
20094
20112
20121

Applicants with the most clearances

Product code KZE
Applicants holding the most 510(k) clearances under product code KZE
ApplicantClearances
Bioject, Inc.7
Derata Corp.6
Equidyne Systems, Inc.5
Medi-Ject Corp.3
Pharmajet, Inc.3
Biovalve Technologies, Inc.2
Felton International, Inc.2
National Medical Products, Inc.2
Vitajet Corp.2
Vitajet Industriae Comercioltda.2

Companies listing this code with FDA

Companies whose registered establishments list this code