# K141872: Sudoscan

- Pathway: 510(k) (Traditional)
- Applicant: Impeto Medical, Inc.
- Decided: Nov 21, 2014 after 133 days
- Product code: GZO (Device, Galvanic Skin Response Measurement)
- Device class: 2
- Regulation: 21 CFR 882.1540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K874850 (1988). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100233: Sudoscan, Impeto Medical (2010) Summary page 4.

## Most influential descendants
- K150804: QBioScan (2015), 0 descendants of its own

## Indications for use
The SUDOSCAN System is a medical device for the measurement of galvanic skin response to aid in the assessment of sudomotor function. SUDOSCAN is indicated for use in the general adult population.

Source page: https://510kreport.com/device/K141872
Methodology: https://510kreport.com/methodology