Cleared Traditional

K172510 - µCor Heart Failure and Arrhythmia Manag...

K172510 is the FDA 510(k) clearance for µCor Heart Failure and Arrhythmia Manag... by Zoll Manufacturing Corporation. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K172510 · Zoll Manufacturing Corporation · Cardiovascular device
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May 2018
Decision
263d
Days
Class 2
Risk

K172510 is an FDA 510(k) clearance for the µCor Heart Failure and Arrhythmia Management System. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Zoll Manufacturing Corporation (Pittsburgh, US). The FDA issued a Cleared decision on May 11, 2018 after a review of 263 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 Zoll Manufacturing Corporation devices

Submission Details

510(k) Number K172510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2017
Decision Date May 11, 2018
Days to Decision 263 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
138d slower than avg
Panel avg: 125d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02975050 Completed Observational Industry-sponsored

Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)

30
Patients (actual)
Condition studied Health Volunteer Validation Study
Eligibility All sexes · 21 Years+ · Healthy volunteers accepted
Sponsor Zoll Medical Corporation (industry)
Started 2016-11-28 → Primary completion 2017-01-19
Primary outcome
Respiratory rate
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

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 K172510.
Multi-parameter Patient Monitor, models C30
K173454 · Shenzhen Comen Medical Instruments Co.,Ltd · Aug 2018
MX40 Release C.01
K180017 · Philips Medical Systems · Jul 2018
ViSi Mobile Monitoring System
K180472 · Sotera Wireless, Inc. · Jun 2018
Tempus Pro Patient Monitor
K173768 · Remote Diagnostic Technologies , Ltd. · Jan 2018
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
K171901 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2017
MX40 Release B.07
K172226 · Philips Medical Systems · Nov 2017