510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250042Unknown

CaRi-Heart

Caristo Diagnostics, Stamford CT / Direct, Unknown
FDA source (opens on fda.gov)

DEN250042 is the FDA 510(k) clearance record for CaRi-Heart, a class II device, cleared for Caristo Diagnostics , Ltd. on under FDA product code SIU (Predictive Indicator For Long-Term Cardiovascular Outcomes). FDA's definition for product code SIU reads: "The predictive indicator for long term cardiovascular outcomes uses software algorithms to analyze inputs such as medical imaging data and cardiovascular risk factors to calculate a risk score, category, or probability that predicts...". FDA records list 3 510(k) clearances for Caristo Diagnostics , Ltd., from to . As of , FDA records show no recalls naming DEN250042.

Clearance record

Decision date
Received
(327 days to decision)
Product code
SIU Predictive Indicator For Long-Term Cardiovascular Outcomes
Regulation
21 CFR 870.2215
Device class
Class II
Review panel
Cardiovascular
Applicant
Caristo Diagnostics , Ltd. 263 Tresser Blvd., 9th Floor, Stamford CT
Third party review
No

Clearances, product code SIU

Trailing 12 months
1 clearance under product code SIU in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SIU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260