Atlas FDA

Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)

FDA 510(k) clearance K251025 · decided 2025-12-29

Clearance details

K-number
K251025
Device name
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
Applicant
Covidien, LLC
Decision
Substantially Equivalent
Date received
2025-04-02
Decision date
2025-12-29
Days to decision
271 days
Clearance type
Traditional
Product code
BZT
Device class
2
Regulation number
868.1920
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Boulder, CO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012)Covidien, LLC2005-06-24
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011)Covidien, LLC2005-02-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006)Covidien, LLC2003-01-07
OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010)Covidien, LLC2002-11-15
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005)Covidien, LLC2002-06-28
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S007)Covidien, LLC2002-04-18