AirLife Adult Heated Wire Circuit

Q: What is the product code of K153234?

The FDA product code is BZE – Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, a Class II (moderate risk) device regulated under 21 CFR 868.5270.

FDA 510(k) K153234 · Carefusion, Inc.

Substantially Equivalent

510(k) numberK153234

Submission

Device name: AirLife Adult Heated Wire Circuit
Applicant: Carefusion, Inc.
Vernon Hills, IL, US
Received: November 9, 2015
Decision date: July 7, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: BZE – Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.5270
Specialty: Anesthesiology

Other 510(k)s with product code BZE

510(k)	Device	Applicant	Decision
K252066	inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit…BZE · Traditional	Vincent Healthcare Products Limited	06/18/2026SE
K253322	Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant…BZE · Traditional	Medline Industries, LP	03/25/2026SE
K243244	Heated Breathing TubeBZE · Traditional	Guangdong Eda Technology Co., Ltd.	07/25/2025SE
K241268	Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)BZE · Traditional	Exceleron Medical	08/02/2024SE
K234032	Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit…BZE · Traditional	Medline Industries, LP	06/04/2024SE
K222822	VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)BZE · Traditional	Draegerwerk AG & CO Kgaa	06/14/2023SE
K201418	Sunset Heated CPAP TubeBZE · Traditional	Sunset Healthcare Solutions, Inc.	01/29/2021SE
K173280	Neonatal ConchaSmart Breathing CircuitsBZE · Traditional	Teleflexmedical, Inc.	08/02/2018SE
K170378	AirLife Adult Heated Wire BiPAP/NIV CircuitBZE · Traditional	Vyaire Medical	09/14/2017SE
K160540	Flexicare Neonatal Heated Wire Breathing SystemBZE · Traditional	Flexicare Medical Limited.	06/23/2016SE

More from Flexicare Medical Limited.

510(k)	Device	Decision
K193088	MaxZero Extension Sets with Needle-Free Connector(s)FPA · Traditional	10/23/2020SE
K151959	AirLife Infant Single Limb Heated Wire CircuitBZE · Traditional	01/20/2016SE

Questions and answers

When was AirLife Adult Heated Wire Circuit cleared by the FDA?

AirLife Adult Heated Wire Circuit (K153234) received a 510(k) decision of Substantially Equivalent on July 7, 2016, 241 days after the submission was received.

What is the product code of K153234?

The FDA product code is BZE – Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, a Class II (moderate risk) device regulated under 21 CFR 868.5270.