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

Container, I.V.

21 CFR 880.5025 / General Hospital
FDA source (opens on fda.gov)

KPE is the FDA product code for Container, I.V., a class II device type, regulated under 21 CFR 880.5025. As of , FDA records hold 117 510(k) clearances under this code, the most recent dated , and 62 recalls.

Classification record

Product code
KPE
Device name
Container, I.V.
Regulation
21 CFR 880.5025
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
Yes
Ingested clearances
117
Ingested recalls
62

Clearances, product code KPE

By decision year
117 clearances under product code KPE with a decision year between 1976 and 2026, 1985 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code KPE by decision year
YearClearances
19761
19773
19793
19801
19819
19822
19837
19849
198511
19862
19875
19882
19897
19903
19915
19936
19944
19951
19961
19973
19983
20002
20021
20033
20042
20061
20081
20091
20112
20121
20131
20193
20201
20212
20232
20241
20252
20263

Applicants with the most clearances

Product code KPE
Applicants holding the most 510(k) clearances under product code KPE
ApplicantClearances
Abbott Medical8
Baxter Healthcare Corporation8
Baxa Corp., Sub. of Cook Group, Inc.5
Gil-Med Industries C/O Kegan & Kegan, Ltd.4
Medi-Plast Intl., Inc.4
Williams Medical Co.4
Advance Medical Designs Inc3
Chartermed, Inc.3
Epic Medical Pte., Ltd.3
Medical & Pharmaceutical Supplies, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 66 companies shown, in name order