Cleared Traditional

AirLife Infant Heated Wire Circuit

K151303 · Care Fusion · Anesthesiology
Jan 2016
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K151303 is an FDA 510(k) clearance for the AirLife Infant Heated Wire Circuit, a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II — Special Controls, product code BZE), submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on January 21, 2016, 248 days after receiving the submission on May 18, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5270.

Submission Details

510(k) Number K151303 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2015
Decision Date January 21, 2016
Days to Decision 248 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZE — Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5270

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