Atlas FDA

BZT

46 FDA 510(k) clearances · Product code

63 daysmedian time to decision
202 days90th percentile
46clearances measured

FDA profile

Official device name
Stethoscope, Esophageal, With Electrical Conductors
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1920
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1997: 1 · 2000: 1 · 2003: 1 · 2008: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) (K251025)Covidien, LLC2025-12-29
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French (K193027)Deroyal Industries, Inc.2020-04-02
ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE (K140134)Starboard Medical, LLC2014-06-16
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR (K111050)Starboard Medical, LLC2012-04-12
ESOPHAGEAL STETHOSCOPE (K092716)Truer Medical, Inc.2009-09-17
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (K072621)Cincinnati Sub-Zero Products, Inc.2007-12-13
LIFESOUND ESOPHAGEAL STETHOSCOPE (K062020)Novamed, LLC2006-09-05
ESOPHAGEAL STETHOSCOPE (K982193)Shore Medical, Inc.1998-09-01
DISPOSABLE ESOPHAGEAL STETHOSCOPE (K973839)Catheter Research, Inc.1998-03-19
ARISTO ESOPHAGEAL STETHOSCOPE (K961060)Aristo Medical Products, Inc.1996-06-19
INTROSCOPE (K953793)Polamedco, Inc.1995-11-29
ESOPHAGEAL STETHOSCOPE (K930929)Coast Medical Corp.1995-03-17
DISPOSABLE ESOPHAGEAL STETHOSCOPE (K943495)Coast Medical, Inc.1994-09-08
DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE (K940169)Deroyal Industries, Inc.1994-07-28
DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE (K925789)Deroyal Industries, Inc.1993-07-13
BNOS MICROVENT(TM), MODEL AC AND MODEL AO (K930533)Bnos Meditech, Ltd.1993-03-29
YSI MODEL 441A AIRWAY TEMPERATURE PROBE (K922007)Yellow Springs Instrument Co., Inc.1992-11-04
TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE (K904943)Arzco Medical Electronics, Inc.1991-04-26
T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE (K894757)Louisville Laboratories, Inc.1989-09-18
YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP (K893409)Yellow Springs Instrument Co., Inc.1989-07-20
VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE (K885347)Vitacomm, Inc.1989-01-30
TELEMETRIC STETHOSCOPE (K882319)Vital Signs, Inc.1988-08-02
SHERIDAN ELECTROSURGERY PROTECTION FILTER (K881293)Sheridan Catheter Corp.1988-06-16
ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS (K874295)Sheridan Catheter Corp.1987-11-24
ESOPHAGEAL STETHOSCOPE W/THERMISTOR (K873344)Medical Components, Inc.1987-10-20
MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM) (K870255)Transcor, Inc.1987-03-26
LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR (K864858)Biomedical Concepts, Inc.1987-03-10
ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T (K864043)Respiratory Support Products, Inc.1986-12-15
ESOPHAGEAL STETHOSCOPE WITH THERMISTOR (K862672)Inmed Corp.1986-10-27
TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER (K862548)Lawrence Medical Systems, Inc.1986-10-22
SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR (K862131)K & S Medicorp1986-07-14
SHERIDAN - YSI/ECG SONATEMP (TM) (K861541)Sheridan Catheter Corp.1986-06-16
ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR (K854212)Respiratory Support Products, Inc.1986-01-03
ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS (K852228)Sensortek, Inc.1985-09-03
ESOPHAGEAL STETHO SCOPE (K844055)Sensortek, Inc.1984-10-25
ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR (K843071)Primrose Medical, Inc.1984-08-24
VITACOMM 100 ESOPHAGEAL STETHOSCOPE (K842309)Vitacomm, Inc.1984-06-22
SHERIDAN YSI/SONATEMP (K841098)Sheridan Catheter Corp.1984-04-30
CARDIO-ESOPHASCOPE (K830716)Portex, Inc.1983-08-12
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO (K823743)Y1983-01-18
CRITIKON #817 ESOPHAGEAL MULTI-PROBE (K821890)Critikon Company, LLC1982-08-03
ARGYLE ACC-U-THERM W/TEMPERATURE PROBE (K812976)Sherwood Medical Co.1981-12-08
LIFESOUND ESOPHAGEAL STETHOSCOPE (K811928)Biomedical Concepts, Inc.1981-07-28
HI-LO TEMP ESOPHAGEAL STETHOSCOPE (K811862)Mallinckrodt Critical Care1981-07-10
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE (K810147)Portex, Inc.1981-02-05
STETHOSCOPE WITH TEMPERATURE SENSOR (K791190)National Catheter Co. Div. Mallinckrodt1979-07-06

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