Cleared Special

K010756 - CH 2000 CARDIAC DIAGNOSTIC SYSTEM

K010756 is an FDA 510(k) clearance for CH 2000 CARDIAC DIAGNOSTIC SYSTEM, manufactured by Cambridge Heart, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 30-day FDA review.

K010756 · Cambridge Heart, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
30d
Days
Class 2
Risk

K010756 is an FDA 510(k) clearance for the CH 2000 CARDIAC DIAGNOSTIC SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Cambridge Heart, Inc. (South West Ranches, US). The FDA issued a Cleared decision on April 12, 2001 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 - K010756

510(k) Number K010756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2001
Decision Date April 12, 2001
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 420
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K010756.
RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC
K012020 · Non-Invasive Monitoring Systems, Inc. · Aug 2001
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K011324 · Cambridge Heart, Inc. · May 2001
SYNETEC
K002817 · Ela Medical, Inc. · May 2001
LOCALISA CARDIAC NAVIGATION SYSTEM
K002869 · Medtronic Surgical Navigation Technologies · Mar 2001
ASTRONOMER+WITH SLD
K003362 · Boston Scientific Corp · Mar 2001
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
K001852 · Itamar Medical (C.M.) 1997 , Ltd. · Feb 2001
K010756 · CH 2000 CARDIAC DIAGNOSTIC SYSTEM
Download PDF FDA Summary Cambridge Heart, Inc.