FDA Product Code QUO: Adjunctive Heart Failure Status Indicator
The Adjunctive Heart Failure Status Indicator Is A Prescription Device Based On Sensor Technology Or Image Data To Provide Information To An Interpreting Clinician In Detecting Heart Failure. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy.
Leading manufacturers include Ultromics Limited, Avicena, LLC and Icardio.Ai.
FDA 510(k) Cleared Adjunctive Heart Failure Status Indicator Devices (Product Code QUO)
About Product Code QUO - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QUO since 2022, with 4 receiving FDA clearance (average review time: 214 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under QUO have taken an average of 238 days to reach a decision - up from 191 days historically. Manufacturers should account for longer review timelines in current project planning.
QUO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →