Cleared Traditional

K100217 - LUCON M-SERIES PATIENT MONITOR

K100217 is the FDA 510(k) clearance for LUCON M-SERIES PATIENT MONITOR by Mediana Co., Ltd.. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K100217 · Mediana Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
134d
Days
Class 2
Risk

K100217 is an FDA 510(k) clearance for the LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Mediana Co., Ltd. (Echo, US). The FDA issued a Cleared decision on June 8, 2010 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Mediana Co., Ltd. devices

Submission Details

510(k) Number K100217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2010
Decision Date June 08, 2010
Days to Decision 134 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
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 275
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K100217.
M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
K102495 · Philips Medical Systems · Sep 2010
BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
K092449 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2010
ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
K101521 · Philips Medical Systems · Jul 2010
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068
K101067 · Philips Medical Systems · May 2010
INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
K093788 · Draeger Medical Systems, Inc. · Mar 2010
12SL ECG ANALYSIS PROGRAM
K092369 · Ge Medical Systems Information Technologies · Feb 2010