DeviceClearance

Product code BZE— Anesthesiology

ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY

Classification name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device class
Class 2
Regulation
21 CFR 868.5270
Advisory panel
Anesthesiology
Total cleared
46
First cleared
Most recent

Market context for product code BZE

FDA has cleared 46 devices under product code BZE between 1976 and 2026, filed by 38 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code BZE

Adverse 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 →

Recent clearances under product code BZE

Data sourced from openFDA. This site is unofficial and independent of the FDA.