FDA Product Code QNV: Adjunctive Hemodynamic Indicator With Decision Point
An Adjunctive Hemodynamic Indicator With Decision Point Is A Device That Identifies And Monitors Hemodynamic Condition(s) Of Interest And Provides Notifications At A Clinically Meaningful Decision Point. This Device Is Intended To Be Used Adjunctively Along With Other Monitoring And Patient Information.
Leading manufacturers include Fifth Eye, Inc..
3
Total
2
Cleared
184d
Avg days
2021
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Adjunctive Hemodynamic Indicator With Decision Point Devices (Product Code QNV)
3 devices
Cleared
Jul 14, 2022
AHI System
Fifth Eye, Inc.
Cardiovascular
79d
Cleared
Dec 03, 2021
AHI System
Fifth Eye, Inc.
Cardiovascular
140d
Not Cleared
Mar 01, 2021
Analytic for Hemodynamic Instability (AHI)
Fifth Eye, Inc.
Cardiovascular
332d
About Product Code QNV - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QNV since 2021, with 2 receiving FDA clearance (average review time: 184 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.