Product Code: BZT FDA class 2 21 CFR 868.1920

Stethoscope, Esophageal, With Electrical Conductors

Anesthesiology

The Stethoscope, Esophageal, with Electrical Conductors is a stethoscope probe designed for insertion into the esophagus to monitor heart and breath sounds from inside the thorax during surgery or anesthesia, with integrated electrical conductors that may serve additional monitoring functions such as temperature measurement. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZT, regulated under 21 CFR 868.1920 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code BZT in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: BZT
Device Class: FDA class 2
Regulation Number: 868.1920
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251025	Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)	Dec 29, 2025	Substantially Equivalent	Covidien, LLC
K193027	Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French	Apr 02, 2020	Substantially Equivalent	Deroyal Industries, Inc.
K140134	ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE	Jun 16, 2014	Substantially Equivalent	Starboard Medical, LLC
K111050	ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR	Apr 12, 2012	Substantially Equivalent	Starboard Medical, LLC
K092716	ESOPHAGEAL STETHOSCOPE	Sep 17, 2009	Substantially Equivalent	Truer Medical, Inc.
K072621	ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR	Dec 13, 2007	Substantially Equivalent	Cincinnati Sub-Zero Products, Inc.
K062020	LIFESOUND ESOPHAGEAL STETHOSCOPE	Sep 05, 2006	Substantially Equivalent	Novamed, LLC
K982193	ESOPHAGEAL STETHOSCOPE	Sep 01, 1998	Substantially Equivalent	Shore Medical, Inc.
K973839	DISPOSABLE ESOPHAGEAL STETHOSCOPE	Mar 19, 1998	Substantially Equivalent	Catheter Research, Inc.
K961060	ARISTO ESOPHAGEAL STETHOSCOPE	Jun 19, 1996	Substantially Equivalent	Aristo Medical Products, Inc.
K953793	INTROSCOPE	Nov 29, 1995	Substantially Equivalent	Polamedco, Inc.
K930929	ESOPHAGEAL STETHOSCOPE	Mar 17, 1995	Substantially Equivalent	Coast Medical Corp.
K943495	DISPOSABLE ESOPHAGEAL STETHOSCOPE	Sep 08, 1994	Substantially Equivalent	Coast Medical, Inc.
K940169	DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE	Jul 28, 1994	Substantially Equivalent	Deroyal Industries, Inc.
K925789	DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE	Jul 13, 1993	Substantially Equivalent	Deroyal Industries, Inc.
K930533	BNOS MICROVENT(TM), MODEL AC AND MODEL AO	Mar 29, 1993	Substantially Equivalent	Bnos Meditech, Ltd.
K922007	YSI MODEL 441A AIRWAY TEMPERATURE PROBE	Nov 04, 1992	Substantially Equivalent	Yellow Springs Instrument Co., Inc.
K904943	TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE	Apr 26, 1991	Substantially Equivalent	Arzco Medical Electronics, Inc.
K894757	T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE	Sep 18, 1989	Substantially Equivalent	Louisville Laboratories, Inc.
K893409	YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP	Jul 20, 1989	Substantially Equivalent	Yellow Springs Instrument Co., Inc.
K885347	VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE	Jan 30, 1989	Substantially Equivalent	Vitacomm, Inc.
K882319	TELEMETRIC STETHOSCOPE	Aug 02, 1988	Substantially Equivalent	Vital Signs, Inc.
K881293	SHERIDAN ELECTROSURGERY PROTECTION FILTER	Jun 16, 1988	Substantially Equivalent	Sheridan Catheter Corp.
K874295	ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS	Nov 24, 1987	Substantially Equivalent	Sheridan Catheter Corp.
K873344	ESOPHAGEAL STETHOSCOPE W/THERMISTOR	Oct 20, 1987	Substantially Equivalent	Medical Components, Inc.
K870255	MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)	Mar 26, 1987	Substantially Equivalent	Transcor, Inc.
K864858	LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR	Mar 10, 1987	Substantially Equivalent	Biomedical Concepts, Inc.
K864043	ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T	Dec 15, 1986	Substantially Equivalent	Respiratory Support Products, Inc.
K862672	ESOPHAGEAL STETHOSCOPE WITH THERMISTOR	Oct 27, 1986	Substantially Equivalent	Inmed Corp.
K862548	TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER	Oct 22, 1986	Substantially Equivalent	Lawrence Medical Systems, Inc.
K862131	SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR	Jul 14, 1986	Substantially Equivalent	K & S Medicorp
K861541	SHERIDAN - YSI/ECG SONATEMP (TM)	Jun 16, 1986	Substantially Equivalent	Sheridan Catheter Corp.
K854212	ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR	Jan 03, 1986	Substantially Equivalent	Respiratory Support Products, Inc.
K852228	ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS	Sep 03, 1985	Substantially Equivalent	Sensortek, Inc.
K844055	ESOPHAGEAL STETHO SCOPE	Oct 25, 1984	Substantially Equivalent	Sensortek, Inc.
K843071	ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR	Aug 24, 1984	Substantially Equivalent	Primrose Medical, Inc.
K842309	VITACOMM 100 ESOPHAGEAL STETHOSCOPE	Jun 22, 1984	Substantially Equivalent	Vitacomm, Inc.
K841098	SHERIDAN YSI/SONATEMP	Apr 30, 1984	Substantially Equivalent	Sheridan Catheter Corp.
K830716	CARDIO-ESOPHASCOPE	Aug 12, 1983	Substantially Equivalent	Portex, Inc.
K823743	MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO	Jan 18, 1983	Substantially Equivalent	Y
K821890	CRITIKON #817 ESOPHAGEAL MULTI-PROBE	Aug 03, 1982	Substantially Equivalent	Critikon Company, LLC
K812976	ARGYLE ACC-U-THERM W/TEMPERATURE PROBE	Dec 08, 1981	Substantially Equivalent	Sherwood Medical Co.
K811928	LIFESOUND ESOPHAGEAL STETHOSCOPE	Jul 28, 1981	Substantially Equivalent	Biomedical Concepts, Inc.
K811862	HI-LO TEMP ESOPHAGEAL STETHOSCOPE	Jul 10, 1981	Substantially Equivalent	Mallinckrodt Critical Care
K810147	ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE	Feb 05, 1981	Substantially Equivalent	Portex, Inc.
K791190	STETHOSCOPE WITH TEMPERATURE SENSOR	Jul 06, 1979	Substantially Equivalent	National Catheter Co. Div. Mallinckrodt