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
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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
Combination Product No
PCCP Authorized No
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 Consultant

Nihon Kohden America, Inc.
Tom Bento

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 417
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K163459.
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
Central Monitoring System
K170514 · Guangdong Biolight Meditech Co., Ltd. · May 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