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. and Icu Medical, Inc..
List of Container, I.v. devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Container, I.v. devices (product code KPE). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →