Cleared Traditional

SLEUTH IMPLANTABLE ECG MONITORING SYSTEM (K063035) - FDA 510(k) Clearance

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

K063035 · Transnoma Medical, Inc. · Cardiovascular device
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Oct 2007
Decision
367d
Days
Class 2
Risk

K063035 is an FDA 510(k) clearance for the SLEUTH IMPLANTABLE ECG MONITORING SYSTEM. Classified as Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (product code MXC), Class II - Special Controls.

Submitted by Transnoma Medical, Inc. (Arden Hills, US). The FDA issued a Cleared decision on October 1, 2007 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Transnoma Medical, Inc. devices

Submission Details

510(k) Number K063035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date October 01, 2007
Days to Decision 367 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
242d slower than avg
Panel avg: 125d · This submission: 367d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MXC Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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.

Regulatory Peers - MXC Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)

All 22
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