FDA Product Code KPE: Container, I.v.
Under FDA product code KPE, intravenous fluid containers are cleared for the storage and delivery of sterile IV solutions.
These flexible plastic bags or rigid bottles contain sterile isotonic, hypertonic, or hypotonic solutions — including saline, dextrose, and lactated Ringer's — for intravenous fluid and electrolyte replacement. They are a fundamental component of fluid therapy across all clinical settings.
KPE devices are Class II medical devices, regulated under 21 CFR 880.5025 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Epic Medical Pte. , Ltd., Beijing L&Z Medical Technology Development Co., Ltd. and Technoflex Sas..
FDA 510(k) Cleared Container, I.v. Devices (Product Code KPE)
About Product Code KPE - Regulatory Context
510(k) Submission Activity
117 total 510(k) submissions under product code KPE since 1976, with 117 receiving FDA clearance (average review time: 108 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under KPE have taken an average of 155 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.
KPE devices are reviewed by the General Hospital panel. Browse all General Hospital devices →