Cleared Special

K112637 - NETKONNECT REMOTE NETWORK EXTENSION

K112637 is an FDA 510(k) clearance for NETKONNECT REMOTE NETWORK EXTENSION, manufactured by Nihon Kohden. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 91-day FDA review.

K112637 · Nihon Kohden · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
91d
Days
Class 2
Risk

K112637 is an FDA 510(k) clearance for the NETKONNECT REMOTE NETWORK EXTENSION. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Nihon Kohden (Foothill Ranch, US). The FDA issued a Cleared decision on December 9, 2011 after a review of 91 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nihon Kohden devices

FDA 510(k) Submission Details - K112637

510(k) Number K112637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2011
Decision Date December 09, 2011
Days to Decision 91 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

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 334
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