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FDA 510(k)

AirLife Adult Heated Wire Circuit

K-Number: K153234 · 2016-07-07

ApplicantCarefusion, Inc.
Decision Date2016-07-07
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AirLife Adult Heated Wire Circuit is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion, Inc.. It received FDA 510(k) clearance on 2016-07-07 under 510(k) number K153234. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirLife Adult Heated Wire Circuit?

AirLife Adult Heated Wire Circuit is a medical device that received FDA 510(k) clearance on 2016-07-07. The listed applicant is Carefusion, Inc.. The 510(k) number is K153234.

When did AirLife Adult Heated Wire Circuit receive FDA 510(k) clearance?

AirLife Adult Heated Wire Circuit received FDA 510(k) clearance on 2016-07-07, under 510(k) number K153234.

Who is the listed applicant for AirLife Adult Heated Wire Circuit?

The FDA 510(k) record lists Carefusion, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirLife Adult Heated Wire Circuit?

The FDA product code for AirLife Adult Heated Wire Circuit is BZE.

Other records listing Carefusion, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193088MaxZero Extension Sets with Needle-Free Connector(s)K151959AirLife Infant Single Limb Heated Wire Circuit

Related Devices (Code: BZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)Vincent Healthcare Products LimitedK253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)Medline Industries, LPK243244Heated Breathing TubeGuangdong Eda Technology Co., Ltd.K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron MedicalK234032Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension LineMedline Industries, LPK222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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