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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K251025

510(k) cleared

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

Covidien, LLC · Dec 29, 2025 · K251025

FDA cleared the Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) from Covidien, LLC on Dec 29, 2025 under K251025, a traditional 510(k). The device falls under product code BZT, Stethoscope, Esophageal, With Electrical Conductors, regulated at 21 CFR 868.1920 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Apr 2, 2025. The decision came 271 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Covidien, LLC has 8 other decisions in the tracker over the last 12 months: K260907 (BIS Advance pEEG Module), K253527 (Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)), K253984 (Instrument Exit Point on Touch Surgery Aide), K253030 (Capnostream35 Portable Respiratory Monitor (PM35MN)).

Questions & Answers

What did FDA clear under K251025?

K251025 is the FDA 510(k) for Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049), submitted by Covidien, LLC. FDA's decision date was Dec 29, 2025, under product code BZT (Stethoscope, Esophageal, With Electrical Conductors).

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

Covidien, LLC, based in Boulder, CO, is the applicant of record for K251025.

How long did the K251025 review take?

FDA received the submission on Apr 2, 2025 and issued its decision on Dec 29, 2025, 271 days later.

← All decisions in December 2025