Cleared Traditional

K240596 - Cerebral Autoregulation Index (CAI) Algorithm (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240596 · Edwards Lifesciences · Neurology device
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Oct 2024
Decision
226d
Days
Class 2
Risk

K240596 is an FDA 510(k) clearance for the Cerebral Autoregulation Index (CAI) Algorithm. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on October 16, 2024 after a review of 226 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.2700 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Edwards Lifesciences devices

Submission Details

510(k) Number K240596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2024
Decision Date October 16, 2024
Days to Decision 226 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 148d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Neurology devices follow this clearance model.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 72
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K240596.
Masimo O3 Regional Oximeter
K243324 · Masimo Corporation · Jul 2025
Lap.Ox™ Laparoscopic Tissue Oximeter
K250519 · Vioptix, Inc. · Jun 2025
ODI-Tech
K241393 · Odi Medical AS · Aug 2024
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