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.
FDA 510(k) Cleared Medium-term Adjunctive Predictive Cardiovascular Indicator Devices (Product Code QNL)
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 - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under QNL have taken an average of 267 days to reach a decision - up from 180 days historically. Manufacturers should account for longer review timelines in current project planning.
QNL devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →