Cleared Traditional

SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 (K023713) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023713 · Sontra Medical, Inc. · Cardiovascular device
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Jan 2004
Decision
450d
Days
Class 2
Risk

K023713 is an FDA 510(k) clearance for the SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000. Classified as Tester, Electrode, Surface, Electrocardiographic (product code KRC), Class II - Special Controls.

Submitted by Sontra Medical, Inc. (Cambridge, US). The FDA issued a Cleared decision on January 28, 2004 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2370 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Sontra Medical, Inc. devices

Submission Details

510(k) Number K023713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2002
Decision Date January 28, 2004
Days to Decision 450 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
325d slower than avg
Panel avg: 125d · This submission: 450d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRC Tester, Electrode, Surface, Electrocardiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.