Cleared Traditional

K212434 - Neuromuscular Transmission Monitor TOF3D (FDA 510(k) Clearance)

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

K212434 · MIPM Mammendorfer Institut f?r Physik und Medizin GmbH · Anesthesiology device
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May 2022
Decision
274d
Days
Class 2
Risk

K212434 is an FDA 510(k) clearance for the Neuromuscular Transmission Monitor TOF3D. 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 May 5, 2022 after a review of 274 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 K212434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2021
Decision Date May 05, 2022
Days to Decision 274 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
135d slower than avg
Panel avg: 139d · This submission: 274d
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 K212434.
Neuromuscular Transmission Monitor TOF3D (2510091)
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K213316 · Nihon Kohden Corporation · Dec 2021