← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

KPE — Container, I.V.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5025
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K252079Beijing L&Z Medical Technology Development Co., Ltd. · 510k2026-04-02
K251980Icu Medical, Inc. · 510k2026-03-20
K251139Fresenius Kabi AG · 510k2026-01-09
K252094Epic Medical Pte. , Ltd. · 510k2025-08-01
K250459Technoflex Sas. · 510k2025-04-18

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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