Cleared Traditional

K153707 - Nihon Kohden Vital Sign Telemeter

K153707 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 254-day FDA review.

K153707 · Nihon Kohden Corporation · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2016
Decision
254d
Days
Class 2
Risk

K153707 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 September 2, 2016 after a review of 254 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 Nihon Kohden Corporation devices

FDA 510(k) Submission Details - K153707

510(k) Number K153707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date September 02, 2016
Days to Decision 254 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
129d slower than avg
Panel avg: 125d · This submission: 254d
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 K153707.
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