Cleared Traditional

Global Hypoperfusion Index (GHI) Algorithm

K231038 · Edwards Lifesciences, LLC · Cardiovascular
Jul 2023
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K231038 is an FDA 510(k) clearance for the Global Hypoperfusion Index (GHI) Algorithm, a Medium-term Adjunctive Predictive Cardiovascular Indicator (Class II — Special Controls, product code QNL), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on July 26, 2023, 105 days after receiving the submission on April 12, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2210.

Submission Details

510(k) Number K231038 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2023
Decision Date July 26, 2023
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QNL — Medium-term Adjunctive Predictive Cardiovascular Indicator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2210
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.