# K250887: Neuromuscular Transmission Monitor TOF3D (2510091)

- Pathway: 510(k) (Traditional)
- Applicant: MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Decided: Oct 21, 2025 after 210 days
- Product code: KOI (Stimulator, Nerve, Peripheral, Electric)
- Device class: 2
- Regulation: 21 CFR 868.2775
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992598 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212434: Neuromuscular Transmission Monitor TOF3D, MIPM Mammendorfer Institut für Physik und Medizin GmbH (2022) Summary page 5.

## Indications for use
The TOF3D is used to objectively monitor the level of neuromuscular transmission by measuring muscle contraction following stimulation. The TOF3D can also be used as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring. The TOF3D is intended for use by specialists, anesthetists and nurses with specialization in anesthesia care. Patients: The device is intended for use for adolescents greater than 18 through 21 years of age, and adults. Excluded operating environment: The device is not designed to be used outdoors, in homecare, ambulances, helicopters, aircraft, submarines, boats, hyperbaric chambers, explosive, flammable and oxygen rich environment or environment with sources of intense electromagnetic disturbances. (e.g. Radio Frequency (RF) shielded room of magnetic resonance imaging equipment, electrophysiology laboratories or areas where short or micro wave therapy equipment is used)

Source page: https://510kreport.com/device/K250887
Methodology: https://510kreport.com/methodology