← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

LHI — Set, I.V. Fluid Transfer

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5440
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES

Recent clearances

K252987Epic Medical Pte. , Ltd. · 510k2026-06-12
K260301Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · 510k2026-06-05
K250345Medline Industries, LP · 510k2025-10-24
K251715Asset Medikal · 510k2025-10-14
K251676Microtek Medical, LLC · 510k2025-09-16
K243404Takeda Pharmaceuticals · 510k2025-07-18
K240761Yukon Medical, LLC · 510k2025-03-21
K243985Icu Medical, Inc. · 510k2025-01-22

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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