Cleared Traditional

Neuromuscular Transmission Monitor TOF3D (2510091)

K250887 · MIPM Mammendorfer Institut f?r Physik und Medizin GmbH · Anesthesiology

Oct 2025

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K250887 is an FDA 510(k) clearance for the Neuromuscular Transmission Monitor TOF3D (2510091), a Stimulator, Nerve, Peripheral, Electric (Class II — Special Controls, product code KOI), submitted by MIPM Mammendorfer Institut f?r Physik und Medizin GmbH (Mammendorf, DE). The FDA issued a Cleared decision on October 21, 2025, 210 days after receiving the submission on March 25, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.

Submission Details

510(k) Number	K250887 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2025
Decision Date	October 21, 2025
Days to Decision	210 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF