DeviceClearance

Product code BZD— Anesthesiology

AirFit N20

Classification name
Ventilator, Non-Continuous (Respirator)
Device class
Class 2
Regulation
21 CFR 868.5905
Advisory panel
Anesthesiology
Total cleared
461
First cleared
Most recent

Market context for product code BZD

FDA has cleared 461 devices under product code BZD between 1977 and 2026, filed by 122 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 BZD

Adverse events under product code BZD

product code BZD
Death
4,440
Injury
53,099
Malfunction
213,222
Other
17
Total
270,778

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 BZD

1–100 of 461

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