DeviceClearance

Product code QNL— Cardiovascular

CLEWICU System

Classification name
Medium-Term Adjunctive Predictive Cardiovascular Indicator
Device class
Class 2
Regulation
21 CFR 870.2210
Advisory panel
Cardiovascular
Total cleared
5
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QNL under 21 CFR 870.2210, via openFDA

Market context for product code QNL

FDA has cleared 5 devices under product code QNL between 2021 and 2024, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QNL

Recent clearances under product code QNL

Data sourced from openFDA. This site is unofficial and independent of the FDA.