Cleared Traditional

K950018 - CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM

K950018 is an FDA 510(k) clearance for CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM, 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 422-day FDA review.

K950018 · Cambridge Heart, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 1996
Decision
422d
Days
Class 2
Risk

K950018 is an FDA 510(k) clearance for the CAMBRIDGE HEART CH 2000 STRESS TEST 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 February 29, 1996 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K950018

510(k) Number K950018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1995
Decision Date February 29, 1996
Days to Decision 422 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
297d slower than avg
Panel avg: 125d · This submission: 422d
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 491
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K950018.
NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER
K955642 · Nellcor Puritan Bennett, Inc. · Jul 1996
PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)
K960449 · Biosensor Corp. · May 1996
CARDIOSMART
K950989 · Hellige GmbH · May 1996
MINISCOPE MS-3
K954066 · Schiller America, Inc. · Oct 1995
HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER
K950004 · Aerotel, Ltd. · Oct 1995
6200 VITAL SIGNS MONITOR
K953415 · Bci Intl., Inc. · Oct 1995
K950018 · CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM
Download PDF Cambridge Heart, Inc.