Cleared Special

K002230 - CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002

K002230 is an FDA 510(k) clearance for CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, manufactured by Cambridge Heart, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Special 510(k) pathway after a 25-day FDA review.

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

FDA 510(k) Submission Details - K002230

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

DRX Device Classification - Class 2, Special Controls

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 147
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K002230.
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247 · Leonhard Lang GmbH · Jan 2003
SKINTACT ECG ELECTRODE
K023503 · Leonhard Lang GmbH · Nov 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · Bio Protech, Inc. · Nov 2002
ECG ELECTRODE (VARIOUS)
K991105 · Conmedcorp · Nov 1999
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · Graphic Controls Corp. · Nov 1998
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
K974445 · 3M Healthcare · Jul 1998