BZC · Class II · 21 CFR 868.1880

FDA Product Code BZC: Calculator, Pulmonary Function Data

Leading manufacturers include Techbopulm, Ltd..

90
Total
90
Cleared
156d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 229d recently vs 155d historically

FDA 510(k) Cleared Calculator, Pulmonary Function Data Devices (Product Code BZC)

90 devices
1–24 of 90
Cleared Sep 17, 2024
STS
K240293
Techbopulm, Ltd.
Anesthesiology · 229d

About Product Code BZC - Regulatory Context

510(k) Submission Activity

90 total 510(k) submissions under product code BZC since 1977, with 90 receiving FDA clearance (average review time: 156 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under BZC have taken an average of 229 days to reach a decision - up from 155 days historically. Manufacturers should account for longer review timelines in current project planning.

BZC devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →