Cleared Traditional

AirLife Adult Heated Wire BiPAP/NIV Circuit

K170378 · Vyaire Medical · Anesthesiology

Sep 2017

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K170378 is an FDA 510(k) clearance for the AirLife Adult Heated Wire BiPAP/NIV Circuit, a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II — Special Controls, product code BZE), submitted by Vyaire Medical (Vernon Hills, US). The FDA issued a Cleared decision on September 14, 2017, 219 days after receiving the submission on February 7, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5270.

Submission Details

510(k) Number	K170378 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2017
Decision Date	September 14, 2017
Days to Decision	219 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