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) Official FDA 510(k) Summary (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.

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 252
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K002230.
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
K020382 · Medicotest A/S · Jun 2002
NEOLEAD
K011564 · Neotech Products, Inc. · Jan 2002
SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
K003804 · Niko Medical Products · Aug 2001
V QUICK PATCH
K993934 · Vq Corp. · Aug 2000
3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
K000690 · Minnesota Mining and Mfg. Co. · May 2000
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
K000206 · Axelgaard Mfg. Co., Ltd. · Apr 2000
K002230 · CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
Download PDF FDA Summary Cambridge Heart, Inc.