FDA Product Code PHC: Infusion Safety Management Software
Drug delivery errors in infusion therapy can have life-threatening consequences. FDA product code PHC covers infusion safety management software used to prevent medication errors.
These clinical decision support systems implement drug libraries with dose-error reduction software that alerts clinicians to potentially unsafe infusion rate and concentration settings before programming begins. They are integrated with smart infusion pumps to create a safety net against programming errors.
PHC devices are Class II medical devices, regulated under 21 CFR 880.5725 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Baxter Healthcare Corporation and Icu Medical, Inc..
List of Infusion Safety Management Software devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Infusion Safety Management Software devices (product code PHC). 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 →