DeviceClearance

Product code PHC— General Hospital

Dose IQ Safety Software

Classification name
Infusion Safety Management Software
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Total cleared
10
First cleared
Most recent

FDA classification definition

“Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.”

— U.S. Food and Drug Administration, device classification record for product code PHC under 21 CFR 880.5725, via openFDA

Market context for product code PHC

FDA has cleared 10 devices under product code PHC between 2014 and 2026, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PHC

Recent clearances under product code PHC

Data sourced from openFDA. This site is unofficial and independent of the FDA.