DeviceClearance

Product code QUO— Cardiovascular

CardioVision

Classification name
Adjunctive Heart Failure Status Indicator
Device class
Class 2
Regulation
21 CFR 870.2200
Advisory panel
Cardiovascular
Total cleared
4
First cleared
Most recent

FDA classification definition

“The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. 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 QUO under 21 CFR 870.2200, via openFDA

Market context for product code QUO

FDA has cleared 4 devices under product code QUO between 2022 and 2025, filed by 3 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 QUO

Recent clearances under product code QUO

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