BZE — Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Class II
FDA Device Classification
Classification Details
- Product Code
- BZE
- Device Class
- Class II
- Regulation Number
- 868.5270
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243244 | guangdong eda technology co | Heated Breathing Tube | July 25, 2025 |
| K241268 | exceleron medical | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | August 2, 2024 |
| K234032 | medline industries | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD9903 | June 4, 2024 |
| K222822 | draegerwerk ag and co kgaa | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (M | June 14, 2023 |
| K201418 | sunset healthcare solutions | Sunset Heated CPAP Tube | January 29, 2021 |
| K173280 | teleflexmedical | Neonatal ConchaSmart Breathing Circuits | August 2, 2018 |
| K170378 | vyaire medical | AirLife Adult Heated Wire BiPAP/NIV Circuit | September 14, 2017 |
| K153234 | carefusion | AirLife Adult Heated Wire Circuit | July 7, 2016 |
| K160540 | flexicare medical limited | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | June 23, 2016 |
| K151461 | plastiflex group | Hybernite RT | March 24, 2016 |
| K151303 | care fusion | AirLife Infant Heated Wire Circuit | January 21, 2016 |
| K151959 | carefusion | AirLife Infant Single Limb Heated Wire Circuit | January 20, 2016 |
| K150900 | flexicare medical | Flexicare Heated Wire Breathing Systems | May 15, 2015 |
| K140424 | respironics | RESPIRONICS REUSABLE HEATED TUBING | November 14, 2014 |
| K122432 | fisher and paykel healthcare | ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS | December 6, 2012 |
| K103767 | fisher and paykel healthcare | DUAL HEATED INFANT VREATHING CIROUITS | April 16, 2012 |
| K110398 | respironics | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | June 1, 2011 |
| K092129 | intersurgical | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2 | May 18, 2010 |
| K100104 | plastiflex group | HYBERNITE RAINOUT CONTROL SYSTEM | April 14, 2010 |
| K034026 | fisher and paykel healthcare | RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS | January 12, 2005 |