Cleared Traditional

K223651 - Cerebral Adaptive Index (CAI) Algorithm

K223651 is the FDA 510(k) clearance for Cerebral Adaptive Index (CAI) Algorithm by Edwards Lifesciences, LLC. It is a Class 2 Neurology device (product code MUD) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K223651 · Edwards Lifesciences, LLC · Neurology device
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May 2023
Decision
171d
Days
Class 2
Risk

K223651 is an FDA 510(k) clearance for the Cerebral Adaptive Index (CAI) Algorithm. 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 May 26, 2023 after a review of 171 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, LLC devices

Submission Details

510(k) Number K223651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2022
Decision Date May 26, 2023
Days to Decision 171 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
23d slower than avg
Panel avg: 148d · This submission: 171d
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 31
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K223651.
OxiplexTS200
K232385 · Iss Medical, Inc. · Mar 2024
Intra.Ox™ 2.0 Handheld Tissue Oximeter
K233488 · Vioptix, Inc. · Feb 2024
Edwards Algorithm for Measurement of Blood Hemoglobin
K230612 · Edwards Lifesciences, LLC · Nov 2023
Masimo O3 Regional Oximeter System
K214072 · Masimo Corporation · May 2022
Intra.Ox 2.0 Handheld Tissue Oximeter
K221010 · Vioptix, Inc. · May 2022
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
K211561 · Covidien, LLC · Dec 2021