# K242525: iTOF®

- Pathway: 510(k) (Traditional)
- Applicant: Nerbio Medical Software Platforms, Inc.
- Decided: Dec 5, 2024 after 101 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 K972698 (1997). 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)
- K172690: ToFscan, Idmed (2018) Summary page 5.

## Indications for use
The iTOF is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.

Source page: https://510kreport.com/device/K242525
Methodology: https://510kreport.com/methodology