Cleared Traditional

K063035 - SLEUTH IMPLANTABLE ECG MONITORING SYSTEM

K063035 is an FDA 510(k) clearance for SLEUTH IMPLANTABLE ECG MONITORING SYSTEM, manufactured by Transnoma Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MXC cleared through the Traditional 510(k) pathway after a 367-day FDA review.

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

FDA 510(k) Submission Details - K063035

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.

MXC Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (MXC) and FDA review panel - the closest regulatory comparables to K063035.
SJM CONFIRM
K122161 · St Jude Medical · Nov 2012
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
K101968 · St Jude Medical · Sep 2010
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
K081365 · St Jude Medical · Aug 2008
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
K011098 · Medtronic Vascular · May 2001
REVEAL PLUS INSERTABLE LOOP RECORDER
K003667 · Medtronic Vascular · Feb 2001
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
K994331 · Medtronic Vascular · Jan 2000