Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1920](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1920) → BZT — Stethoscope, Esophageal, With Electrical Conductors # BZT · Stethoscope, Esophageal, With Electrical Conductors _Anesthesiology · 21 CFR 868.1920 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT ## Overview - **Product Code:** BZT - **Device Name:** Stethoscope, Esophageal, With Electrical Conductors - **Regulation:** [21 CFR 868.1920](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1920) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes ## Identification An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 46) Showing 20 most recent of 46 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251025](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K251025.md) | Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | Covidien, LLC | Dec 29, 2025 | SESE | | [K193027](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K193027.md) | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French | Deroyal Industries, Inc. | Apr 2, 2020 | SESE | | [K140134](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K140134.md) | ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE | Starboard Medical, LLC | Jun 16, 2014 | SESE | | [K111050](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K111050.md) | ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR | Starboard Medical, LLC | Apr 12, 2012 | SESE | | [K092716](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K092716.md) | ESOPHAGEAL STETHOSCOPE | Truer Medical, Inc. | Sep 17, 2009 | SESE | | [K072621](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K072621.md) | ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR | Cincinnati Sub-Zero Products, Inc. | Dec 13, 2007 | SESE | | [K062020](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K062020.md) | LIFESOUND ESOPHAGEAL STETHOSCOPE | Novamed, LLC | Sep 5, 2006 | SESE | | [K982193](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K982193.md) | ESOPHAGEAL STETHOSCOPE | Shore Medical, Inc. | Sep 1, 1998 | SESE | | [K973839](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K973839.md) | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Catheter Research, Inc. | Mar 19, 1998 | SESE | | [K961060](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K961060.md) | ARISTO ESOPHAGEAL STETHOSCOPE | Aristo Medical Products, Inc. | Jun 19, 1996 | SESE | | [K953793](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K953793.md) | INTROSCOPE | Polamedco, Inc. | Nov 29, 1995 | SESE | | [K930929](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K930929.md) | ESOPHAGEAL STETHOSCOPE | Coast Medical Corp. | Mar 17, 1995 | SESE | | [K943495](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K943495.md) | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Coast Medical, Inc. | Sep 8, 1994 | SESE | | [K940169](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K940169.md) | DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE | Deroyal Industries, Inc. | Jul 28, 1994 | SESE | | [K925789](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K925789.md) | DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE | Deroyal Industries, Inc. | Jul 13, 1993 | SESE | | [K930533](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K930533.md) | BNOS MICROVENT(TM), MODEL AC AND MODEL AO | Bnos Meditech, Ltd. | Mar 29, 1993 | SESE | | [K922007](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K922007.md) | YSI MODEL 441A AIRWAY TEMPERATURE PROBE | Yellow Springs Instrument Co., Inc. | Nov 4, 1992 | SESE | | [K904943](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K904943.md) | TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE | Arzco Medical Electronics, Inc. | Apr 26, 1991 | SESE | | [K894757](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K894757.md) | T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE | Louisville Laboratories, Inc. | Sep 18, 1989 | SESE | | [K893409](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K893409.md) | YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP | Yellow Springs Instrument Co., Inc. | Jul 20, 1989 | SESE | ## Top Applicants - Sheridan Catheter Corp. — 4 clearances - Deroyal Industries, Inc. — 3 clearances - Biomedical Concepts, Inc. — 2 clearances - Portex, Inc. — 2 clearances - Respiratory Support Products, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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