Cleared Traditional

K223651 - Cerebral Adaptive Index (CAI) Algorithm

K223651 is an FDA 510(k) clearance for Cerebral Adaptive Index (CAI) Algorithm, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K223651

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.

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 58
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