BZT · Class II · 21 CFR 868.1920

FDA Product Code BZT: Stethoscope, Esophageal, With Electrical Conductors

Leading manufacturers include Covidien, LLC.

46
Total
46
Cleared
102d
Avg days
1979
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 271d recently vs 98d historically

FDA 510(k) Cleared Stethoscope, Esophageal, With Electrical Conductors Devices (Product Code BZT)

46 devices
1–24 of 46
Cleared Dec 29, 2025
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
K251025
Covidien, LLC
Anesthesiology · 271d

About Product Code BZT - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code BZT since 1979, with 46 receiving FDA clearance (average review time: 102 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 BZT have taken an average of 271 days to reach a decision - up from 98 days historically. Manufacturers should account for longer review timelines in current project planning.

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