# K212434: Neuromuscular Transmission Monitor TOF3D

- Pathway: 510(k) (Traditional)
- Applicant: MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Decided: May 5, 2022 after 274 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: 1 generation back to K992598 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992598: Tof-Watch SX, Organon Teknika Corp. (1999) Summary page 4.

## Most influential descendants
- K250887: Neuromuscular Transmission Monitor TOF3D (2510091) (2025), 0 descendants of its own

## 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 device is intended for use for adolescents greater than 18 through 21 years of age, and adults.

Source page: https://510kreport.com/device/K212434
Methodology: https://510kreport.com/methodology