Cleared Traditional

K981697 - CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM

K981697 is an FDA 510(k) clearance for CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOS..., manufactured by Cambridge Heart, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K981697 · Cambridge Heart, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
156d
Days
Class 2
Risk

K981697 is an FDA 510(k) clearance for the CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cambridge Heart, Inc. (Bedford, US). The FDA issued a Cleared decision on October 14, 1998 after a review of 156 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 Cambridge Heart, Inc. devices

FDA 510(k) Submission Details - K981697

510(k) Number K981697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1998
Decision Date October 14, 1998
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
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 326
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K981697.
MODEL APS ALTERNANS PROCESSING SYSTEM
K001034 · Cambridge Heart, Inc. · Jun 2000
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
K000645 · General Electric Medical Systems Information Techn · May 2000
MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
K991786 · General Electric Medical Systems Information Techn · Nov 1999
ANS 2000 ECG MONITOR AND RESPIRATION PACER
K973426 · D. E. Hokanson, Inc. · Aug 1998
M1765A ECG MANAGER
K974746 · Hewlett-Packard Co. · Mar 1998
FORMULA FOR ARCHIMED
K974079 · Biosound Esaote, Inc. · Jan 1998