510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251293Substantially Equivalent

CardioVision

Icardio.Ai, West Hollywood CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251293 is the FDA 510(k) clearance record for CardioVision, a class II device, cleared for Icardio.Ai on under FDA product code QUO (Adjunctive Heart Failure Status Indicator). FDA's definition for product code QUO reads: "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...". FDA records list 2 510(k) clearances for Icardio.Ai, from to . As of , FDA records show no recalls naming K251293.

Clearance record

Decision date
Received
(210 days to decision)
Product code
QUO Adjunctive Heart Failure Status Indicator
Regulation
21 CFR 870.2200
Device class
Class II
Review panel
Cardiovascular
Applicant
Icardio.Ai 8601 Beverly Blvd., West Hollywood CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QUO

Trailing 12 months
1 clearance under product code QUO in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QUO, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260