Cleared Traditional

K240596 - Cerebral Autoregulation Index (CAI) Alg...

K240596 is an FDA 510(k) clearance for Cerebral Autoregulation Index (CAI) Alg..., manufactured by Edwards Lifesciences. The device is a Class 2 Neurology device with product code MUD cleared through the Traditional 510(k) pathway after a 226-day FDA review.

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

FDA 510(k) Submission Details - K240596

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.

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 Neurology devices follow this clearance model.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 38
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K240596.
Spectrum-2
K254129 · Neko Health AB · May 2026
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