inspired Heated Breathing Circuit (510-008) +3 more— 510(k) K252066
Substantially EquivalentVincent Healthcare Products Limited
FDA 510(k) clearance K252066 for inspired Heated Breathing Circuit (510-008) +3 more, Substantially Equivalent on 2026-06-18. Applicant: Vincent Healthcare Products Limited. Device class: 2.
Summary
Vincent Healthcare Products' clearance covers two inspired Heated Breathing Circuits (510-008 and 510-009) and two inspired Auto-feed Humidification Chambers (VHC10 and VHC20). The record lists one product code, BZE, breathing system heaters with or without a controller (not humidifiers or nebulizers).
Class II, 21 CFR 868.5270. Anesthesiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Vincent Healthcare filed from Kowloon, Hong Kong. The decision came 352 calendar days after receipt (July 1, 2025 to June 18, 2026).
Clearance details
- Device name as filed
- 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
- Product code
- Product code BZE
- Device class
- Class 2
- Regulation
- 21 CFR 868.5270
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kowloon, HK
Recent devices under product code BZE
view all- K253322 — 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)
- K243244 — Heated Breathing Tube
- K241268 — Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
- K234032 — Hudson RCI Dri-Tech Breathing Circuits +6 more
- K222822 — VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
More clearances from Vincent Healthcare Products Limited
view allAdverse events under product code BZE
product code BZE- Death
- 4
- Malfunction
- 910
- Other
- 1
- Total
- 915
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.