Cleared Traditional

K163459 - Nihon Kohden Vital Sign Telemeter

K163459 is an FDA 510(k) clearance for Nihon Kohden Vital Sign Telemeter, manufactured by Nihon Kohden Corporation. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K163459 · Nihon Kohden Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
116d
Days
Class 2
Risk

K163459 is an FDA 510(k) clearance for the Nihon Kohden Vital Sign Telemeter. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on April 4, 2017 after a review of 116 days - within the typical 510(k) review window.

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 Nihon Kohden Corporation devices

FDA 510(k) Submission Details - K163459

510(k) Number K163459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2016
Decision Date April 04, 2017
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
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 320
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K163459.
M3290B Philips IntelliVue Information Center iX
K163584 · Philips Medical Systems · Jul 2017
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
K171621 · Welch Allyn, Inc. · Jun 2017
EK12 Algorithm
K170155 · Ge Medical Systems Information Technologies, Inc. · Jun 2017
Telemetry Transmitter
K161056 · Edan Instruments, Inc. · Feb 2017
Mortara Surveyor Patient Monitor
K161517 · Mortara Instrument, Inc. · Jan 2017
Patient Monitor
K160981 · Edan Instruments, Inc. · Dec 2016