Cleared Traditional

C50 and C80 Multi-parameter Patient Monitor (K191106) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191106 · Shenzhen Comen Medical Instruments Co.,Ltd · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
232d
Days
Class 2
Risk

K191106 is an FDA 510(k) clearance for the C50 and C80 Multi-parameter Patient Monitor. 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 December 13, 2019 after a review of 232 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

Submission Details

510(k) Number K191106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2019
Decision Date December 13, 2019
Days to Decision 232 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
107d slower than avg
Panel avg: 125d · This submission: 232d
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 160
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K191106.
CARESCAPE B650
K191149 · GE Healthcare Finland Oy · Jan 2020
Carescape One
K190008 · Ge Healthcare · Dec 2019
ZOLL Arrhythmia Management Sysyem
K190939 · Zoll Manufacturing Corporation · Dec 2019
IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3
K182979 · Philips Medizin Systeme Boeblingen GmbH · Nov 2019
ePM Series Patient monitors
K191769 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2019
M3290B Patient Information Center iX
K183387 · Philips Medical Systems · Aug 2019