510(k) K234032
- Device
- Hudson 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; HUD
- Applicant
- Medline Industries, LP
- 510(k) number
- K234032
- Product code
- BZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-04
- Date received
- 2023-12-20
- 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
Related Records
Applicant Contact
- Contact
- Phyllis Kondor
- Address
- Three Lakes Dr. Northfiled IL US 60093 60093
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
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10197344043132 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2024-11-28 |
| 10197344043125 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2024-11-28 |
| 20197344043092 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2024-11-22 |
| 20197344043085 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2024-11-22 |
| 20197344043054 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2024-11-22 |
| 20197344043047 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2024-11-22 |
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 |
| K243244 | Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. | 2025-07-25 |
| K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Exceleron Medical | 2024-08-02 |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | Draegerwerk AG & CO Kgaa | 2023-06-14 |
| 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 |