Cleared Special

K010758 - HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS

K010758 is an FDA 510(k) clearance for HEARTWAVE 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 30-day FDA review.

K010758 · Cambridge Heart, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
30d
Days
Class 2
Risk

K010758 is an FDA 510(k) clearance for the HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS. 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 April 12, 2001 after a review of 30 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.

FDA 510(k) Submission Details - K010758

510(k) Number K010758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2001
Decision Date April 12, 2001
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 491
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K010758.
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K011177 · Bci, Inc. · May 2001
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K010955 · Boston Medical Technologies, Inc. · Apr 2001
AB CARDIETTE START 200 HV
K010822 · H&C Medical Devices Spa · Apr 2001
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
K010505 · Brentwood Medical Technology Corp. · Mar 2001
VERTEX SYSTEM
K002822 · Medical Positioning, Inc. · Jan 2001
CARDIO MONITOR CENTER VISION
K003392 · Shl Telemedicine International , Ltd. · Jan 2001
K010758 · HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
Download PDF FDA Summary Cambridge Heart, Inc.