Cleared Special

CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 (K002230) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K002230 · Cambridge Heart, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
25d
Days
Class 2
Risk

K002230 is an FDA 510(k) clearance for the CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Cambridge Heart, Inc. (South West Ranches, US). The FDA issued a Cleared decision on August 18, 2000 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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

Submission Details

510(k) Number K002230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2000
Decision Date August 18, 2000
Days to Decision 25 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 328
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K002230.
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MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · Medtronic Vascular · Jul 1990
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080 · 3M Company · Jul 1990
RED DOT CARDIAC SENSOR SYSTEM
K896155 · 3M Company · Dec 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · C.R. Bard, Inc. · Mar 1989