Cleared Traditional

K170378 - AirLife Adult Heated Wire BiPAP/NIV Cir...

K170378 is the FDA 510(k) clearance for AirLife Adult Heated Wire BiPAP/NIV Cir... by Vyaire Medical. It is a Class 2 Anesthesiology device (product code BZE) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K170378 · Vyaire Medical · Anesthesiology device
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Sep 2017
Decision
219d
Days
Class 2
Risk

K170378 is an FDA 510(k) clearance for the AirLife Adult Heated Wire BiPAP/NIV Circuit. Classified as Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer within the BZE classification (a category for neonatal and pediatric respiratory circuit components), Class II - Special Controls.

Submitted by Vyaire Medical (Vernon Hills, US). The FDA issued a Cleared decision on September 14, 2017 after a review of 219 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5270 - the FDA anesthesiology and respiratory 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. Neonatal respiratory circuit components typically face extended FDA review due to heightened safety scrutiny for pediatric patient populations - the 176-day cycle reflects this additional regulatory diligence.

View all Vyaire Medical devices

Submission Details

510(k) Number K170378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 140d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5270
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

All 20
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K170378.
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
K222822 · Draegerwerk AG & CO Kgaa · Jun 2023
Sunset Heated CPAP Tube
K201418 · Sunset Healthcare Solutions, Inc. · Jan 2021
Neonatal ConchaSmart Breathing Circuits
K173280 · Teleflexmedical, Inc. · Aug 2018
AirLife Infant Heated Wire Circuit
K151303 · Care Fusion · Jan 2016
RESPIRONICS REUSABLE HEATED TUBING
K140424 · Respironics, Inc. · Nov 2014
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
K122432 · Fisher &Paykel Healthcare , Ltd. · Dec 2012