BZE
- Product code
- BZE
- Device name
- Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5270
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 46 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252066 | 2026-06-18 | Vincent Healthcare Products Limited | inspired Heated Breathing Circuit (510-008); inspir… | |
| K253322 | 2026-03-25 | Medline Industries, LP | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HU… | |
| K243244 | 2025-07-25 | Guangdong Eda Technology Co., Ltd. | Heated Breathing Tube | |
| K241268 | 2024-08-02 | Exceleron Medical | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15… | FDA |
| K234032 | 2024-06-04 | Medline Industries, LP | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri… |
Official FDA classification page: BZE
Classification and pathway per current FDA publications. Data from openFDA (CC0).