510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231038Substantially Equivalent

Global Hypoperfusion Index (GHI) Algorithm

Edwards Lifesciences LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231038 is the FDA 510(k) clearance record for Global Hypoperfusion Index (GHI) Algorithm, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator). FDA's definition for product code QNL reads: "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...". FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show no recalls naming K231038.

Clearance record

Decision date
Received
(105 days to decision)
Product code
QNL Medium-Term Adjunctive Predictive Cardiovascular Indicator
Regulation
21 CFR 870.2210
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences, LLC 1 Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNL

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