510(k) K252066— inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)

Substantially Equivalent

Vincent Healthcare Products Limited

Clearance details

Applicant: Vincent Healthcare Products Limited
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 2025-07-01
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kowloon, HK

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.