Cleared Traditional

K180482 - ZOLL Propaq M

K180482 is an FDA 510(k) clearance for ZOLL Propaq M, manufactured by ZOLL Medical Corporation. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K180482 · ZOLL Medical Corporation · Cardiovascular device
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Nov 2018
Decision
280d
Days
Class 2
Risk

K180482 is an FDA 510(k) clearance for the ZOLL Propaq M. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by ZOLL Medical Corporation (Chelsmford, US). The FDA issued a Cleared decision on November 30, 2018 after a review of 280 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 Medical Corporation devices

FDA 510(k) Submission Details - K180482

510(k) Number K180482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2018
Decision Date November 30, 2018
Days to Decision 280 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
155d slower than avg
Panel avg: 125d · This submission: 280d
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 398
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K180482.
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
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BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
K182075 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2018
IntelliVue Multi-Measurement Module MMX
K181831 · Philips Medizin Systeme Boeblingen GmbH · Nov 2018
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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