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.
4
Total
4
Cleared
214d
Avg days
2022
Since
Declining activity -
1 submissions in the last 2 years
vs 3 in the prior period
Consistent review times:
210d avg (recent)
FDA 510(k) Cleared Adjunctive Heart Failure Status Indicator Devices (Product Code QUO)
4 devices
Cleared
Nov 21, 2025
CardioVision
Icardio.Ai
Cardiovascular
210d
Cleared
Sep 23, 2024
EchoGo Heart Failure (2.0)
Ultromics Limited
Cardiovascular
265d
Cleared
Oct 06, 2023
Vivio® LVEDP System
Avicena, LLC
Cardiovascular
282d
Cleared
Nov 23, 2022
EchoGo Heart Failure
Ultromics Limited
Cardiovascular
100d
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 declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - QUO Product Code
FDA review times for QUO submissions have been consistent, averaging 210 days recently vs 216 days historically.
QUO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →