Decision Date2024-08-02
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) is the device name listed in this FDA 510(k) record. The listed applicant is Exceleron Medical. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241268. 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 Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)?
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Exceleron Medical. The 510(k) number is K241268.
When did Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) receive FDA 510(k) clearance?
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241268.
Who is the listed applicant for Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)?
The FDA 510(k) record lists Exceleron Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)?
The FDA product code for Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) is BZE.
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.K234032Hudson 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 KgaaK201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.