510(k) K243244

Device: Heated Breathing Tube
Applicant: Guangdong Eda Technology Co., Ltd.
510(k) number: K243244
Product code: BZE
Decision: Substantially Equivalent (SESE)
Decision date: 2025-07-25
Date received: 2024-10-11
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: N

Related Records

Applicant Contact

Contact: Kant Huang
Address: # 6, Ma'An 2nd Rd., Chashan Town Guangdong Province CN 523393 523393

FDA Registration Numbers

3029906224
9611500
3017520736
3001313714
9710644
9615827
3003898360
3014766741
3029706818
3042507287
3023272766
3015928685
3008342612
3015084765
3008264065
3011120183
8022265
3013095415
3001400310
3021039857
1225492
2028807
3021244152
2518422
3030149975
2085602
1417592
3002797442
3007220521
3016723884
3006446479
3001421318
3007709321
3010834934
3008331339
9611451
3006061749
8030673
1000604079
3011137372
3018783526
3013557562
3000126629
3020460367
3008567544
3002807267
8021995
1314417
3004050971
3004365956

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code BZE

510(k)	Device	Applicant	Decision date
K253322	Hudson 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, LP	2026-03-25
K241268	Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)	Exceleron Medical	2024-08-02
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K201418	Sunset Heated CPAP Tube	Sunset Healthcare Solutions, Inc.	2021-01-29
K173280	Neonatal ConchaSmart Breathing Circuits	Teleflexmedical, Inc.	2018-08-02
K170378	AirLife Adult Heated Wire BiPAP/NIV Circuit	Vyaire Medical	2017-09-14
K153234	AirLife Adult Heated Wire Circuit	Carefusion, Inc.	2016-07-07
K160540	FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM	Flexicare Medical Limited.	2016-06-23
K151461	Hybernite RT	Plastiflex Group NV	2016-03-24
K151303	AirLife Infant Heated Wire Circuit	Care Fusion	2016-01-21
K151959	AirLife Infant Single Limb Heated Wire Circuit	Carefusion, Inc.	2016-01-20
K150900	Flexicare Heated Wire Breathing Systems	Flexicare Medical, Ltd.	2015-05-15
K140424	RESPIRONICS REUSABLE HEATED TUBING	Respironics, Inc.	2014-11-14
K122432	ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS	Fisher & Paykel Healthcare, Ltd.	2012-12-06