QNV · Class II · 21 CFR 870.2220

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
1–3 of 3
Cleared Jul 14, 2022
AHI System
K221203
Fifth Eye, Inc.
Cardiovascular · 79d
Cleared Dec 03, 2021
AHI System
K212219
Fifth Eye, Inc.
Cardiovascular · 140d
Not Cleared Mar 01, 2021
Analytic for Hemodynamic Instability (AHI)
DEN200022
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.

QNV devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →