inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)
FDA 510(k) K252066 · Vincent Healthcare Products Limited
510(k) numberK252066
Submission
- Device name
- inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)
- Applicant
- Vincent Healthcare Products Limited
Kowloon, HK - Received
- July 1, 2025
- Decision date
- June 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZE – Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5270
- Specialty
- Anesthesiology
Other 510(k)s with product code BZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant…BZE · Traditional | Medline Industries, LP | 03/25/2026SE |
| K243244 | Heated Breathing TubeBZE · Traditional | Guangdong Eda Technology Co., Ltd. | 07/25/2025SE |
| K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)BZE · Traditional | Exceleron Medical | 08/02/2024SE |
| K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit…BZE · Traditional | Medline Industries, LP | 06/04/2024SE |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)BZE · Traditional | Draegerwerk AG & CO Kgaa | 06/14/2023SE |
| K201418 | Sunset Heated CPAP TubeBZE · Traditional | Sunset Healthcare Solutions, Inc. | 01/29/2021SE |
| K173280 | Neonatal ConchaSmart Breathing CircuitsBZE · Traditional | Teleflexmedical, Inc. | 08/02/2018SE |
| K170378 | AirLife Adult Heated Wire BiPAP/NIV CircuitBZE · Traditional | Vyaire Medical | 09/14/2017SE |
| K153234 | AirLife Adult Heated Wire CircuitBZE · Traditional | Carefusion, Inc. | 07/07/2016SE |
| K160540 | Flexicare Neonatal Heated Wire Breathing SystemBZE · Traditional | Flexicare Medical Limited. | 06/23/2016SE |
More from Flexicare Medical Limited.
| 510(k) | Device | Decision |
|---|---|---|
| K222351 | inspired VHB20 Heated HumidifierBTT · Traditional | 12/21/2022SE |
Questions and answers
When was inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20) cleared by the FDA?
inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20) (K252066) received a 510(k) decision of Substantially Equivalent on June 18, 2026, 352 days after the submission was received.
What is the product code of K252066?
The FDA product code is BZE – Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, a Class II (moderate risk) device regulated under 21 CFR 868.5270.