Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BZT — Predicate Candidate Screening
46 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
202 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251025 | Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor | Covidien, LLC | 2025-12-29 | 271 | 0 |
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 F | Deroyal Industries, Inc. | 2020-04-02 | 155 | 0 |
| K140134 | ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE) | Starboard Medical, LLC | 2014-06-16 | 150 | 0 |
| K111050 | ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL | Starboard Medical, LLC | 2012-04-12 | 363 | 0 |
| K092716 | ESOPHAGEAL STETHOSCOPE | Truer Medical, Inc. | 2009-09-17 | 14 | 0 |
| K072621 | ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCO | Cincinnati Sub-Zero Products, Inc. | 2007-12-13 | 87 | 1 |
| K062020 | LIFESOUND ESOPHAGEAL STETHOSCOPE | Novamed, LLC | 2006-09-05 | 50 | 0 |
| K982193 | ESOPHAGEAL STETHOSCOPE | Shore Medical, Inc. | 1998-09-01 | 71 | 0 |
| K973839 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Catheter Research, Inc. | 1998-03-19 | 162 | 0 |
| K961060 | ARISTO ESOPHAGEAL STETHOSCOPE | Aristo Medical Products, Inc. | 1996-06-19 | 93 | 0 |
| K953793 | INTROSCOPE | Polamedco, Inc. | 1995-11-29 | 107 | 0 |
| K930929 | ESOPHAGEAL STETHOSCOPE | Coast Medical Corp. | 1995-03-17 | 752 | 0 |
| K943495 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Coast Medical, Inc. | 1994-09-08 | 51 | 0 |
| K940169 | DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULT | Deroyal Industries, Inc. | 1994-07-28 | 202 | 0 |
| K925789 | DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE | Deroyal Industries, Inc. | 1993-07-13 | 239 | 0 |
| K930533 | BNOS MICROVENT(TM), MODEL AC AND MODEL AO | Bnos Meditech, Ltd. | 1993-03-29 | 55 | 0 |
| K922007 | YSI MODEL 441A AIRWAY TEMPERATURE PROBE | Yellow Springs Instrument Co., Inc. | 1992-11-04 | 188 | 0 |
| K904943 | TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE | Arzco Medical Electronics, Inc. | 1991-04-26 | 176 | 0 |
| K894757 | T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE | Louisville Laboratories, Inc. | 1989-09-18 | 53 | 0 |
| K893409 | YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP | Yellow Springs Instrument Co., Inc. | 1989-07-20 | 71 | 0 |
| K885347 | VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE | Vitacomm, Inc. | 1989-01-30 | 33 | 0 |
| K882319 | TELEMETRIC STETHOSCOPE | Vital Signs, Inc. | 1988-08-02 | 57 | 0 |
| K881293 | SHERIDAN ELECTROSURGERY PROTECTION FILTER | Sheridan Catheter Corp. | 1988-06-16 | 80 | 0 |
| K874295 | ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS | Sheridan Catheter Corp. | 1987-11-24 | 35 | 0 |
| K873344 | ESOPHAGEAL STETHOSCOPE W/THERMISTOR | Medical Components, Inc. | 1987-10-20 | 62 | 0 |
| K870255 | MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM) | Transcor, Inc. | 1987-03-26 | 63 | 0 |
| K864858 | LIFESOUND(TM) ESOPHAGEAL STETHOSCOPE W/THERMISTOR | Biomedical Concepts, Inc. | 1987-03-10 | 89 | 0 |
| K864043 | ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T | Respiratory Support Products, Inc. | 1986-12-15 | 60 | 0 |
| K862672 | ESOPHAGEAL STETHOSCOPE WITH THERMISTOR | Inmed Corp. | 1986-10-27 | 105 | 0 |
| K862548 | TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER | Lawrence Medical Systems, Inc. | 1986-10-22 | 111 | 0 |
| K862131 | SALTZMAN EAR(TM) ENDOTRACHEAL ASCULTATION RECEPTOR | K & S Medicorp | 1986-07-14 | 40 | 0 |
| K861541 | SHERIDAN - YSI/ECG SONATEMP (TM) | Sheridan Catheter Corp. | 1986-06-16 | 53 | 0 |
| K854212 | ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR | Respiratory Support Products, Inc. | 1986-01-03 | 78 | 0 |
| K852228 | ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS | Sensortek, Inc. | 1985-09-03 | 104 | 0 |
| K844055 | ESOPHAGEAL STETHO SCOPE | Sensortek, Inc. | 1984-10-25 | 7 | 0 |
| K843071 | ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR | Primrose Medical, Inc. | 1984-08-24 | 18 | 0 |
| K842309 | VITACOMM 100 ESOPHAGEAL STETHOSCOPE | Vitacomm, Inc. | 1984-06-22 | 10 | 0 |
| K841098 | SHERIDAN YSI/SONATEMP | Sheridan Catheter Corp. | 1984-04-30 | 48 | 0 |
| K830716 | CARDIO-ESOPHASCOPE | Portex, Inc. | 1983-08-12 | 157 | 0 |
| K823743 | MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO | Y | 1983-01-18 | 36 | 0 |
| K821890 | CRITIKON #817 ESOPHAGEAL MULTI-PROBE | Critikon Company, LLC | 1982-08-03 | 39 | 0 |
| K812976 | ARGYLE ACC-U-THERM W/TEMPERATURE PROBE | Sherwood Medical Co. | 1981-12-08 | 46 | 0 |
| K811928 | LIFESOUND ESOPHAGEAL STETHOSCOPE | Biomedical Concepts, Inc. | 1981-07-28 | 22 | 0 |
| K811862 | HI-LO TEMP ESOPHAGEAL STETHOSCOPE | Mallinckrodt Critical Care | 1981-07-10 | 9 | 0 |
| K810147 | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE | Portex, Inc. | 1981-02-05 | 15 | 0 |
| K791190 | STETHOSCOPE WITH TEMPERATURE SENSOR | National Catheter Co. Div. Mallinckrodt | 1979-07-06 | 10 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda