510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230612Substantially Equivalent

Edwards Algorithm for Measurement of Blood Hemoglobin

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

K230612 is the FDA 510(k) clearance record for Edwards Algorithm for Measurement of Blood Hemoglobin, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code MUD (Oximeter, Tissue Saturation). FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show no recalls naming K230612.

Clearance record

Decision date
Received
(256 days to decision)
Product code
MUD Oximeter, Tissue Saturation
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences, LLC One Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUD

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