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 Baxter Healthcare Corp, Abbott Laboratories and Baxa Corp., Sub. of Cook Group, Inc..