Cleared Special

K033711 - FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM

K033711 is an FDA 510(k) clearance for FUKUDA DENSHI DYNASCOPE MODEL DS-5000 C..., manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 190-day FDA review.

K033711 · Fukuda Denshi USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
190d
Days
Class 2
Risk

K033711 is an FDA 510(k) clearance for the FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM. 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 June 3, 2004 after a review of 190 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. 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.

FDA 510(k) Submission Details - K033711

510(k) Number K033711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2003
Decision Date June 03, 2004
Days to Decision 190 days
Submission Type Special
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
65d slower than avg
Panel avg: 125d · This submission: 190d
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 429
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K033711.
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K033711 · FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM
Download PDF FDA Summary Fukuda Denshi USA, In…