510(k) · Cleared

Cleared

Sonoprep Impedance Diagnostics (Idx) System, Model D1000

K023713510(k) TraditionalCleared Jan 28, 2004450-day reviewClass II21 CFR 870.2370

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sontra Medical, Inc. · KRC Tester, Electrode, Surface, Electrocardiographic

Cleared on Jan 28, 2004 as substantially equivalent to K782079 (Quinton, Inc., 1979) after a 450-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.

Decided: Jan 28, 2004
Review: 450 days
Class: Class II
Product code: KRC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K782079 (1979). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK782079 Electrode System, Quik-PrepQuinton, Inc. · 1979
This deviceK023713 Sonoprep Impedance Diagnostics (Idx) System, Model D1000Sontra Medical, Inc. · 2004
Descendant · cites it directly · 0 of its ownK040525 Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic…Sontra Medical, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all

K040525Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000Sontra Medical, Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K782079	Electrode System, Quik-Prep	Quinton, Inc.	1979	—
0 (this device)	K023713	Sonoprep Impedance Diagnostics (Idx) System, Model D1000	Sontra Medical, Inc.	2004	—
+1	K040525	Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model…	Sontra Medical, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K023713, 1979–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KRC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K782079	Electrode System, Quik-Prep Summary page 1 …0.2360, Electrocardiograph Electrode. Predicate Device: Quinton, Inc. QuikPrep Electrode System, K782079 Device Description: The Sontra Medical Corporation SonoPre…	Quinton, Inc.	1979	—

Also cleared against K782079: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040525	Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000	Sontra Medical, Inc.	2004	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K040525 (Sontra Medical, Inc., 2004) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K782079.

How does its category compare?

All KRC devices

KRC Tester, Electrode, Surface, Electrocardiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRC

FDA has decided no KRC device since 2007.

Median 510(k) review, days · KRC

Too few KRC 510(k)s in any year since 2007 to give a median.

Recalls per year · KRC

No recall names KRC since 2007.

Adverse event reports per year · KRC

No MAUDE report names KRC since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023713 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023713: Sonoprep Impedance Diagnostics (Idx) System, Model D1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023713

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026