Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
Summary
Covidien, LLC received 510(k) clearance for Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049), a BZT device. Cleared on 2025-12-29.
Details
Source
510(k) Clearance
External ID
K251025
Action Date
2025-12-29
Status
Traditional
Category
device
Product Code
BZT
Product Description
Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049). Product code: BZT.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 413 device clearances issued this month. Covidien, LLC has received 20 total clearances in our database.
Covidien, LLC has 61 FDA actions in our database, including 41 recalls and 20 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Covidien, LLC have FDA actions?
Covidien, LLC has 61 FDA actions in our database, including 41 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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