Cleared Traditional

µCor Heart Failure and Arrhythmia Management System (K172510) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K172510 · Zoll Manufacturing Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 424
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K172510.
Radius VSM and Accessories
K254209 · Masimo Corporation · Jun 2026
M12 Telemetry System
K252840 · Global Instrumentation, LLC · May 2026
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
K260098 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2026
Vista CMS
K250349 · Shanghai Draeger Medical Instrument Co., Ltd. · Apr 2026
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
K253170 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2026
Vista 300/Vista 300 S
K252250 · Shanghai Draeger Medical Instrument Co., Ltd. · Apr 2026