FDA.reportPublic FDA data

510(k) K241268

Device
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
Applicant
Exceleron Medical
510(k) number
K241268
Product code
BZE
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-02
Date received
2024-05-06
Regulation
868.5270
Classification name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Keith Roberts
Address
5000 Township Pkwy. St. Paul MN US 55110 55110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BZE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253322Hudson 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, LP2026-03-25
K243244Heated Breathing TubeGuangdong Eda Technology Co., Ltd.2025-07-25
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K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa2023-06-14
K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.2021-01-29
K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc.2018-08-02
K170378AirLife Adult Heated Wire BiPAP/NIV CircuitVyaire Medical2017-09-14
K153234AirLife Adult Heated Wire CircuitCarefusion, Inc.2016-07-07
K160540FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMFlexicare Medical Limited.2016-06-23
K151461Hybernite RTPlastiflex Group NV2016-03-24
K151303AirLife Infant Heated Wire CircuitCare Fusion2016-01-21
K151959AirLife Infant Single Limb Heated Wire CircuitCarefusion, Inc.2016-01-20
K150900Flexicare Heated Wire Breathing SystemsFlexicare Medical, Ltd.2015-05-15
K140424RESPIRONICS REUSABLE HEATED TUBINGRespironics, Inc.2014-11-14
K122432ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITSFisher & Paykel Healthcare, Ltd.2012-12-06