# K023713: Sonoprep Impedance Diagnostics (Idx) System, Model D1000

- Pathway: 510(k) (Traditional)
- Applicant: Sontra Medical, Inc.
- Decided: Jan 28, 2004 after 450 days
- Product code: KRC (Tester, Electrode, Surface, Electrocardiographic)
- Device class: 2
- Regulation: 21 CFR 870.2370
- 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 K782079 (1979). 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)
- K782079: Electrode System, Quik-Prep, Quinton, Inc. (1979) Summary page 1.

## Most influential descendants
- K040525: Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000 (2004), 0 descendants of its own

## Indications for use
The Sontra Medical Corporation SonoPrepTM Impedance Diagnostics (IDx) System is intended to be used for preparation of intact skin to lower skin impedance. The supplied electrodes are intended to be used for ECG monitoring. Clinical results demonstrated that the SonoPrep 1Dx reduced skin impedance for 24 hours when used in conjunction with the supplied ECG electrodes; with some patients developing skin irritation. However, any skin irritation resolved within a 24 hour period.

Source page: https://510kreport.com/device/K023713
Methodology: https://510kreport.com/methodology