# K172690: ToFscan

- Pathway: 510(k) (Traditional)
- Applicant: Idmed
- Decided: May 31, 2018 after 267 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 K972698 (1997). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972698: Tof-Watch, Organon Teknika Corp. (1997) Summary page 4.

## Most influential descendants
- K220530: Tetragraph Neuromuscular Transmission Monitor (2022), 1 descendant of its own
- K261098: TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) (2026), 0 descendants of its own
- K243339: WiTOF (2025), 0 descendants of its own
- K242525: iTOF® (2024), 0 descendants of its own

## Indications for use
The TOFscan is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit. The effect of neuromuscular blocking agents (NMBAs) is monitored by measuring the acceleration of the muscle movement (acceleromyography) or by visually observing muscle contractions consequent to electrical stimulation. The TOFscan has a three-dimensional acceleration sensor (accelerometer) to detect and quantify a patient’s thumb movement (contracting adductor pollicis). The sensor is directly integrated into the finger’s splint, making it possible to obtain its optimal and reproducible positioning.

Source page: https://510kreport.com/device/K172690
Methodology: https://510kreport.com/methodology