Cleared Traditional

K173454 - Multi-parameter Patient Monitor

K173454 is an FDA 510(k) clearance for Multi-parameter Patient Monitor, manufactured by Shenzhen Comen Medical Instruments Co.,Ltd. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K173454 · Shenzhen Comen Medical Instruments Co.,Ltd · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
283d
Days
Class 2
Risk

K173454 is an FDA 510(k) clearance for the Multi-parameter Patient Monitor, models C30. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Shenzhen Comen Medical Instruments Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on August 16, 2018 after a review of 283 days - an extended review cycle.

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 Shenzhen Comen Medical Instruments Co.,Ltd devices

FDA 510(k) Submission Details - K173454

510(k) Number K173454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2017
Decision Date August 16, 2018
Days to Decision 283 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
158d slower than avg
Panel avg: 125d · This submission: 283d
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 319
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K173454.
IntelliVue Multi-Measurement Module MMX
K181831 · Philips Medizin Systeme Boeblingen GmbH · Nov 2018
Surveyor Patient Monitor
K173765 · Mortara Instrument, Inc. · Sep 2018
IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
K181314 · Philips Medizin Systeme Boeblingen GmbH · Sep 2018
MX40 Release C.01
K180017 · Philips Medical Systems · Jul 2018
ViSi Mobile Monitoring System
K180472 · Sotera Wireless, Inc. · Jun 2018
µCor Heart Failure and Arrhythmia Management System
K172510 · Zoll Manufacturing Corporation · May 2018