BTG · Class II · 21 CFR 874.4680

FDA Product Code BTG: Brush, Biopsy, Bronchoscope (non-rigid)

If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

Leading manufacturers include Olympus Medical Systems Corporation.

6
Total
6
Cleared
184d
Avg days
1978
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 49d recently vs 210d historically

FDA 510(k) Cleared Brush, Biopsy, Bronchoscope (non-rigid) Devices (Product Code BTG)

6 devices
1–6 of 6
Cleared Jun 12, 2025
Disposable Cytology Brush BC-202D/203D Series
K251279
Olympus Medical Systems Corporation
Anesthesiology · 49d

About Product Code BTG - Regulatory Context

510(k) Submission Activity

6 total 510(k) submissions under product code BTG since 1978, with 6 receiving FDA clearance (average review time: 184 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 BTG have taken an average of 49 days to reach a decision - down from 210 days historically, suggesting improved FDA processing for this classification.

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