Cleared Special

K001034 - MODEL APS ALTERNANS PROCESSING SYSTEM

K001034 is an FDA 510(k) clearance for MODEL APS ALTERNANS PROCESSING 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 70-day FDA review.

K001034 · Cambridge Heart, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
70d
Days
Class 2
Risk

K001034 is an FDA 510(k) clearance for the MODEL APS ALTERNANS PROCESSING SYSTEM. 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 June 9, 2000 after a review of 70 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.

View all Cambridge Heart, Inc. devices

FDA 510(k) Submission Details - K001034

510(k) Number K001034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2000
Decision Date June 09, 2000
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
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 326
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K001034.
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K981697 · Cambridge Heart, Inc. · Oct 1998