# K232210: X-trodes System M

- Pathway: 510(k) (Traditional)
- Applicant: X-Trodes
- Decided: Feb 4, 2024 after 193 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K903644 (1991). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203331: Quick-20m, Cgx, LLC (2021) Summary page 5.
- K222902: Electrocardiograph: SE-1200 Pro and SE-1201 Pro, Edan Instruments, Inc. (2023). Cleared while this submission was under review Summary page 6.
- K102610: Focus Emg Device, Teleemg, LLC USA (2011) Summary page 6.

## Indications for use
The X-trodes System M is intended for prescription use only in the home or healthcare facility to acquire, record, transmit and display physiological signals from adult patients. The X-trodes System M acquires, records, transmits, and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer and gyroscope signals. The X-trodes System M only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.

Source page: https://510kreport.com/device/K232210
Methodology: https://510kreport.com/methodology