Cleared Traditional

K052511 - CARDIOFAX CE

K052511 is an FDA 510(k) clearance for CARDIOFAX CE, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K052511 · Nihon Kohden America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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May 2006
Decision
252d
Days
Class 2
Risk

K052511 is an FDA 510(k) clearance for the CARDIOFAX CE, MODEL ECG-1500 A. 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 May 24, 2006 after a review of 252 days - an extended review cycle.

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

FDA 510(k) Submission Details - K052511

510(k) Number K052511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2005
Decision Date May 24, 2006
Days to Decision 252 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
127d slower than avg
Panel avg: 125d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

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 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K052511.
MORTARA ELI 10 ELECTROCARDIOGRAPH
K070539 · Mortara Instrument, Inc. · Mar 2007
ELI 350 ELECTROCARDIOGRAPH
K062677 · Mortara Instrument, Inc. · Nov 2006
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
K060766 · Omron Healthcare, Inc. · Jun 2006
PHILIPS 12-LEAD ALGORITHM
K052049 · Philips Medical Systems · Aug 2005
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
K050074 · Welch Allyn, Inc. · Mar 2005
CARDIOFAX CE, MODEL PEA-1110K
K042827 · Nihon Kohden America, Inc. · Jan 2005