Cleared Traditional

K250887 - Neuromuscular Transmission Monitor TOF3D (2510091) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250887 · MIPM Mammendorfer Institut f?r Physik und Medizin GmbH · Anesthesiology device
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Oct 2025
Decision
210d
Days
Class 2
Risk

K250887 is an FDA 510(k) clearance for the Neuromuscular Transmission Monitor TOF3D (2510091). Classified as Stimulator, Nerve, Peripheral, Electric (product code KOI), Class II - Special Controls.

Submitted by MIPM Mammendorfer Institut f?r Physik und Medizin GmbH (Mammendorf, DE). The FDA issued a Cleared decision on October 21, 2025 after a review of 210 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all MIPM Mammendorfer Institut f?r Physik und Medizin GmbH devices

Submission Details

510(k) Number K250887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 139d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOI Stimulator, Nerve, Peripheral, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - KOI Stimulator, Nerve, Peripheral, Electric

All 27
Devices cleared under the same product code (KOI) and FDA review panel - the closest regulatory comparables to K250887.
WiTOF
K243339 · Idmed · Jun 2025
iTOF®
K242525 · Nerbio Medical Software Platforms, Inc. · Dec 2024
Tetragraph Neuromuscular Transmission Monitor
K220530 · Senzime AB · Aug 2022
Life Scope PT BSM-1700 Series Bedside Monitor
K220976 · Nihon Kohden Corporation · Jul 2022
Neuromuscular Transmission Monitor TOF3D
K212434 · MIPM Mammendorfer Institut f?r Physik und Medizin GmbH · May 2022
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
K213316 · Nihon Kohden Corporation · Dec 2021