BZT · Class II · 21 CFR 868.1920

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

Leading manufacturers include Sheridan Catheter Corp., Deroyal Industries, Inc. and Vital Signs, Inc..

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
Cleared Apr 02, 2020
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
K193027
Deroyal Industries, Inc.
Anesthesiology · 155d
Cleared Jul 28, 1994
DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE
K940169
Deroyal Industries, Inc.
Anesthesiology · 202d
Cleared Jul 13, 1993
DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
K925789
Deroyal Industries, Inc.
Anesthesiology · 239d
Cleared Aug 02, 1988
TELEMETRIC STETHOSCOPE
K882319
Vital Signs, Inc.
Anesthesiology · 57d
Cleared Jun 16, 1988
SHERIDAN ELECTROSURGERY PROTECTION FILTER
K881293
Sheridan Catheter Corp.
Anesthesiology · 80d
Cleared Nov 24, 1987
ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS
K874295
Sheridan Catheter Corp.
Anesthesiology · 35d
Cleared Oct 20, 1987
ESOPHAGEAL STETHOSCOPE W/THERMISTOR
K873344
Medical Components, Inc.
Anesthesiology · 62d
Cleared Jun 16, 1986
SHERIDAN - YSI/ECG SONATEMP (TM)
K861541
Sheridan Catheter Corp.
Anesthesiology · 53d
Cleared Apr 30, 1984
SHERIDAN YSI/SONATEMP
K841098
Sheridan Catheter Corp.
Anesthesiology · 48d
Cleared Jan 18, 1983
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
K823743
Y
Anesthesiology · 36d
Cleared Aug 03, 1982
CRITIKON #817 ESOPHAGEAL MULTI-PROBE
K821890
Critikon Company, LLC
Anesthesiology · 39d
Cleared Dec 08, 1981
ARGYLE ACC-U-THERM W/TEMPERATURE PROBE
K812976
Sherwood Medical Co.
Anesthesiology · 46d
Cleared Jul 10, 1981
HI-LO TEMP ESOPHAGEAL STETHOSCOPE
K811862
Mallinckrodt Critical Care
Anesthesiology · 9d

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 510(k) Review Time - BZT Product Code

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 →