Cleared Traditional

K140847 - CARDIOSPY ECG HOLTER SYSTEMS

K140847 is an FDA 510(k) clearance for CARDIOSPY ECG HOLTER SYSTEMS, manufactured by Labtech Kft.. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K140847 · Labtech Kft. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
246d
Days
Class 2
Risk

K140847 is an FDA 510(k) clearance for the CARDIOSPY ECG HOLTER SYSTEMS. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Labtech Kft. (Debrecen, HU). The FDA issued a Cleared decision on December 5, 2014 after a review of 246 days - an extended review cycle.

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. Standard predicate reliance. 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 Labtech Kft. devices

FDA 510(k) Submission Details - K140847

510(k) Number K140847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2014
Decision Date December 05, 2014
Days to Decision 246 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
121d slower than avg
Panel avg: 125d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLO Device Classification - Class 2, Special Controls

Product Code MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
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 - MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

All 8
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K140847.
RX-1 Rhythm Express Remote Cardiac Monitoring System
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CER-S
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SEER MC
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CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410
K043454 · Medicomp, Inc. · Mar 2005
H-SCRIBE
K004017 · Mortara Instrument, Inc. · Jun 2001