FDA Product Code QNL: Medium-term Adjunctive Predictive Cardiovascular Indicator
The Adjunctive Predictive Cardiovascular Indicator Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict Future Cardiovascular Status Or Events Within A Defined Medium-term Period. 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 Clew Medical , Ltd., Implicity, Inc. and Edwards Lifesciences, LLC.
5
Total
5
Cleared
197d
Avg days
2021
Since
Declining activity -
0 submissions in the last 2 years
vs 4 in the prior period
FDA 510(k) Cleared Medium-term Adjunctive Predictive Cardiovascular Indicator Devices (Product Code QNL)
5 devices
Cleared
Jun 21, 2024
eCARTv5 Clinical Deterioration Suite (“eCART”)
Agilemd, Inc.
Cardiovascular
267d
Cleared
Jan 13, 2024
CLEWICU System
Clew Medical , Ltd.
Cardiovascular
107d
Cleared
Oct 25, 2023
SignalHF (IM008)
Implicity, Inc.
Cardiovascular
211d
Cleared
Jul 26, 2023
Global Hypoperfusion Index (GHI) Algorithm
Edwards Lifesciences, LLC
Cardiovascular
105d
Cleared
Jan 09, 2021
CLEWICU System (ClewICUServer and ClewICUnitor)
Clew Medical , Ltd.
Cardiovascular
297d
About Product Code QNL - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QNL since 2021, with 5 receiving FDA clearance (average review time: 197 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.