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) clearance K252066 · decided 2026-06-18
Clearance details
- K-number
- K252066
- 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
- Decision
- Substantially Equivalent
- Date received
- 2025-07-01
- Decision date
- 2026-06-18
- Days to decision
- 352 days
- Clearance type
- Traditional
- Product code
- BZE
- Device class
- 2
- Regulation number
- 868.5270
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Kowloon, HK
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Vincent Healthcare Products Limited
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| 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) (K253322) | Medline Industries, LP | 2026-03-25 |
| Heated Breathing Tube (K243244) | Guangdong Eda Technology Co., Ltd. | 2025-07-25 |
| Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) (K241268) | Exceleron Medical | 2024-08-02 |
| 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; HUD901/Dri-Tech Ventilator Accessory Extension Line (K234032) | Medline Industries, LP | 2024-06-04 |
| VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) (K222822) | Draegerwerk AG & CO Kgaa | 2023-06-14 |
| Sunset Heated CPAP Tube (K201418) | Sunset Healthcare Solutions, Inc. | 2021-01-29 |
| Neonatal ConchaSmart Breathing Circuits (K173280) | Teleflexmedical, Inc. | 2018-08-02 |
| AirLife Adult Heated Wire BiPAP/NIV Circuit (K170378) | Vyaire Medical | 2017-09-14 |
| AirLife Adult Heated Wire Circuit (K153234) | Carefusion, Inc. | 2016-07-07 |
| FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM (K160540) | Flexicare Medical Limited. | 2016-06-23 |
| Hybernite RT (K151461) | Plastiflex Group NV | 2016-03-24 |
| AirLife Infant Heated Wire Circuit (K151303) | Care Fusion | 2016-01-21 |
Recalls involving this device
No recalls on record reference this clearance.