Cleared Traditional

K173036 - North-vision Multi-parameter Patient Monitor (FDA 510(k) Clearance)

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

K173036 · North-Vision Tech., Inc. · Cardiovascular device
Dec 2018
Decision
449d
Days
Class 2
Risk

K173036 is an FDA 510(k) clearance for the North-vision Multi-parameter Patient Monitor. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by North-Vision Tech., Inc. (Hsinchu City, TW). The FDA issued a Cleared decision on December 21, 2018 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

Submission Details

510(k) Number K173036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2017
Decision Date December 21, 2018
Days to Decision 449 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 140d · This submission: 449d
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 34
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K173036.
IntelliVue Multi-Measurement Module X3 (867030)
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IntelliVue Patient monitors MX400, MX450, MX500, MX550
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IntelliVue Patient Monitor 6100 (6100)
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