Cleared Special

QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V (K072060) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K072060 · Nihon Kohden America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
21d
Days
Class 2
Risk

K072060 is an FDA 510(k) clearance for the QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on August 17, 2007 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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. Low regulatory complexity profile. 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 America, Inc. devices

Submission Details

510(k) Number K072060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2007
Decision Date August 17, 2007
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 122
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K072060.
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
K101569 · Taidoc Technology Corporation · Mar 2011
MAC 1600 ECG ANALYSIS SYSTEM
K081437 · Ge Medical Systems Information Technologies · Jul 2008
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
K072217 · Nihon Kohden America, Inc. · Aug 2007
CARDIOFAX CE, MODEL ECG-1500 A
K052511 · Nihon Kohden America, Inc. · May 2006
CARDIOFAX CE, MODEL PEA-1110K
K042827 · Nihon Kohden America, Inc. · Jan 2005
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K042177 · Ge Medical Systems Information Technologies · Aug 2004