WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / October 2025 / K250887

510(k) cleared

Neuromuscular Transmission Monitor TOF3D (2510091)

MIPM Mammendorfer Institut für Physik und Medizin GmbH · Oct 21, 2025 · K250887

FDA cleared the Neuromuscular Transmission Monitor TOF3D (2510091) from MIPM Mammendorfer Institut für Physik und Medizin GmbH on Oct 21, 2025 under K250887, a traditional 510(k). The device falls under product code KOI, Stimulator, Nerve, Peripheral, Electric, regulated at 21 CFR 868.2775 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Mar 25, 2025. The decision came 210 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for MIPM Mammendorfer Institut für Physik und Medizin GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250887?

K250887 is the FDA 510(k) for Neuromuscular Transmission Monitor TOF3D (2510091), submitted by MIPM Mammendorfer Institut für Physik und Medizin GmbH. FDA's decision date was Oct 21, 2025, under product code KOI (Stimulator, Nerve, Peripheral, Electric).

Who makes the Neuromuscular Transmission Monitor TOF3D (2510091)?

MIPM Mammendorfer Institut für Physik und Medizin GmbH, based in Mammendorf, is the applicant of record for K250887.

How long did the K250887 review take?

FDA received the submission on Mar 25, 2025 and issued its decision on Oct 21, 2025, 210 days later.

← All decisions in October 2025