BZE — Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Class II
FDA product code BZE covers "Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer", a Class II medical device regulated under 21 CFR 868.5270. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K252066 | vincent healthcare products limited | inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit | June 18, 2026 |
| K253322 | medline industries | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 I | March 25, 2026 |
| 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 |