Cleared Special

K013565 - CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000

K013565 is an FDA 510(k) clearance for CARDIAC DIAGNOSTIC SYSTEM, manufactured by Cambridge Heart, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 26-day FDA review.

K013565 · Cambridge Heart, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
26d
Days
Class 2
Risk

K013565 is an FDA 510(k) clearance for the CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cambridge Heart, Inc. (South West Ranches, US). The FDA issued a Cleared decision on November 21, 2001 after a review of 26 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.

FDA 510(k) Submission Details - K013565

510(k) Number K013565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2001
Decision Date November 21, 2001
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 491
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K013565.
CAIRD TECHNOLOGY HOLTER 2000
K012686 · Caird Technology · Dec 2001
CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
K013367 · Reynolds Medical , Ltd. · Dec 2001
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K013564 · Cambridge Heart, Inc. · Nov 2001
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
K012263 · National Custom Ent., Inc. · Oct 2001
MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
K012264 · National Custom Ent., Inc. · Oct 2001
BLY-501 ADAPTOR
K012540 · Micromedical Industries, Ltd. · Sep 2001
K013565 · CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
Download PDF FDA Summary Cambridge Heart, Inc.