Cleared Traditional

FUKUDA DENSHI (K103134) - FDA 510(k) Clearance

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

K103134 · Fukuda Denshi USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
137d
Days
Class 2
Risk

K103134 is an FDA 510(k) clearance for the FUKUDA DENSHI. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on March 11, 2011 after a review of 137 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 Fukuda Denshi USA, Inc. devices

Submission Details

510(k) Number K103134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2010
Decision Date March 11, 2011
Days to Decision 137 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
12d slower than avg
Panel avg: 125d · This submission: 137d
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 103
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K103134.
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
K171621 · Welch Allyn, Inc. · Jun 2017
Telemetry Transmitter
K161056 · Edan Instruments, Inc. · Feb 2017
AVIVO Mobile Patient Management (MPM) System
K153160 · Medtronic, Inc. · Mar 2016
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO
K031340 · Siemens Medical Solutions USA, Inc. · Nov 2003
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K030738 · Siemens Medical Solutions USA, Inc. · Jun 2003
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K030313 · Siemens Medical Solutions USA, Inc. · Feb 2003