Cleared Traditional

K112190 - PATIENT MONITOR

K112190 is an FDA 510(k) clearance for PATIENT MONITOR, manufactured by Mediana Co., Ltd.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K112190 · Mediana Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
103d
Days
Class 2
Risk

K112190 is an FDA 510(k) clearance for the PATIENT MONITOR. 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 November 9, 2011 after a review of 103 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

FDA 510(k) Submission Details - K112190

510(k) Number K112190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2011
Decision Date November 09, 2011
Days to Decision 103 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 125d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

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 398
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K112190.
PATIENT MONITOR
K113623 · Edan Instruments, Inc. · Feb 2012
AVIVO MOBILE PATIENT MANAGEMENT
K113187 · Corventis, Inc. · Jan 2012
NETKONNECT REMOTE NETWORK EXTENSION
K112637 · Nihon Kohden · Dec 2011
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
K112962 · Spacelabs Medical, Inc. · Nov 2011
PATIENT MONITOR
K112803 · Guangdong Biolight Meditech Co., Ltd. · Oct 2011
PATIENT MONITOR
K110922 · Edan Instruments, Inc. · Jul 2011