Cleared Traditional

K123711 - PATIENT MONITOR

K123711 is an FDA 510(k) clearance for PATIENT MONITOR, manufactured by Shenzhen Creative Industry Co., Ltd.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K123711 · Shenzhen Creative Industry Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
301d
Days
Class 2
Risk

K123711 is an FDA 510(k) clearance for the PATIENT MONITOR. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Shenzhen Creative Industry Co., Ltd. (Echo, US). The FDA issued a Cleared decision on October 1, 2013 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Shenzhen Creative Industry Co., Ltd. devices

FDA 510(k) Submission Details - K123711

510(k) Number K123711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2012
Decision Date October 01, 2013
Days to Decision 301 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
176d slower than avg
Panel avg: 125d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 158
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K123711.
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
K132807 · Welch Allyn, Inc. · Jan 2014
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K132604 · Covidien · Dec 2013
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
K132808 · Welch Allyn, Inc. · Nov 2013
MRI PATIENT MONITORING SYSTEM
K132359 · Invivo Corporation · Aug 2013
EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL
K131382 · Invivo Corporation · Jul 2013
740 SELECT
K130411 · Cas Medical Systems, Inc. · May 2013