Cleared Traditional

Cerebral Adaptive Index (CAI) Algorithm

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

About This 510(k) Submission

K223651 is an FDA 510(k) clearance for the Cerebral Adaptive Index (CAI) Algorithm, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on May 26, 2023, 171 days after receiving the submission on December 6, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K223651 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MUD — Oximeter, Tissue Saturation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700