FDA Product Code BZT: Stethoscope, Esophageal, With Electrical Conductors
Leading manufacturers include Sheridan Catheter Corp., Deroyal Industries, Inc. and Respiratory Support Products, 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
Cleared
Dec 29, 2025
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
Covidien, LLC
Anesthesiology
271d
Cleared
Apr 02, 2020
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
Deroyal Industries, Inc.
Anesthesiology
155d
Cleared
Jun 16, 2014
ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
Starboard Medical, LLC
Anesthesiology
150d
Cleared
Apr 12, 2012
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
Starboard Medical, LLC
Anesthesiology
363d
Cleared
Sep 01, 1998
ESOPHAGEAL STETHOSCOPE
Shore Medical, Inc.
Anesthesiology
71d
Cleared
Mar 19, 1998
DISPOSABLE ESOPHAGEAL STETHOSCOPE
Catheter Research, Inc.
Anesthesiology
162d
Cleared
Jun 19, 1996
ARISTO ESOPHAGEAL STETHOSCOPE
Aristo Medical Products, Inc.
Anesthesiology
93d
Cleared
Nov 29, 1995
INTROSCOPE
Polamedco, Inc.
Anesthesiology
107d
Cleared
Jul 28, 1994
DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE
Deroyal Industries, Inc.
Anesthesiology
202d
Cleared
Jul 13, 1993
DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
Deroyal Industries, Inc.
Anesthesiology
239d
Cleared
Nov 04, 1992
YSI MODEL 441A AIRWAY TEMPERATURE PROBE
Yellow Springs Instrument Co., Inc.
Anesthesiology
188d
Cleared
Jul 20, 1989
YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
Yellow Springs Instrument Co., Inc.
Anesthesiology
71d
Cleared
Aug 02, 1988
TELEMETRIC STETHOSCOPE
Vital Signs, Inc.
Anesthesiology
57d
Cleared
Jun 16, 1988
SHERIDAN ELECTROSURGERY PROTECTION FILTER
Sheridan Catheter Corp.
Anesthesiology
80d
Cleared
Nov 24, 1987
ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS
Sheridan Catheter Corp.
Anesthesiology
35d
Cleared
Oct 20, 1987
ESOPHAGEAL STETHOSCOPE W/THERMISTOR
Medical Components, Inc.
Anesthesiology
62d
Cleared
Dec 15, 1986
ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T
Respiratory Support Products, Inc.
Anesthesiology
60d
Cleared
Oct 27, 1986
ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
Inmed Corp.
Anesthesiology
105d
Cleared
Jun 16, 1986
SHERIDAN - YSI/ECG SONATEMP (TM)
Sheridan Catheter Corp.
Anesthesiology
53d
Cleared
Jan 03, 1986
ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR
Respiratory Support Products, Inc.
Anesthesiology
78d
Cleared
Apr 30, 1984
SHERIDAN YSI/SONATEMP
Sheridan Catheter Corp.
Anesthesiology
48d
Cleared
Aug 12, 1983
CARDIO-ESOPHASCOPE
Portex, Inc.
Anesthesiology
157d
Cleared
Jan 18, 1983
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
Y
Anesthesiology
36d
Cleared
Aug 03, 1982
CRITIKON #817 ESOPHAGEAL MULTI-PROBE
Critikon Company, LLC
Anesthesiology
39d
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 →