Cleared Traditional

K230612 - Edwards Algorithm for Measurement of Blood Hemoglobin

K230612 is an FDA 510(k) clearance for Edwards Algorithm for Measurement of Bl..., manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K230612 · Edwards Lifesciences, LLC · Cardiovascular device
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Nov 2023
Decision
256d
Days
Class 2
Risk

K230612 is an FDA 510(k) clearance for the Edwards Algorithm for Measurement of Blood Hemoglobin. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on November 17, 2023 after a review of 256 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K230612

510(k) Number K230612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2023
Decision Date November 17, 2023
Days to Decision 256 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 125d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUD Device Classification - Class 2, Special Controls

Product Code MUD Oximeter, Tissue Saturation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 58
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K230612.
SnapshotNIR model KD205
K240601 · Kent Imaging, Inc. · Apr 2024
OxiplexTS200
K232385 · Iss Medical, Inc. · Mar 2024
Intra.Ox™ 2.0 Handheld Tissue Oximeter
K233488 · Vioptix, Inc. · Feb 2024
Cerebral Adaptive Index (CAI) Algorithm
K223651 · Edwards Lifesciences, LLC · May 2023
Masimo O3 Regional Oximeter System
K214072 · Masimo Corporation · May 2022
Intra.Ox 2.0 Handheld Tissue Oximeter
K221010 · Vioptix, Inc. · May 2022