Cleared Abbreviated

K002197 - CARTOUCH

K002197 is an FDA 510(k) clearance for CARTOUCH, manufactured by Cardionics, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Abbreviated 510(k) pathway after a 160-day FDA review.

K002197 · Cardionics, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
160d
Days
Class 2
Risk

K002197 is an FDA 510(k) clearance for the CARTOUCH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardionics, Inc. (Puyallup, US). The FDA issued a Cleared decision on December 27, 2000 after a review of 160 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K002197

510(k) Number K002197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2000
Decision Date December 27, 2000
Days to Decision 160 days
Submission Type Abbreviated
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
35d slower than avg
Panel avg: 125d · This submission: 160d
Pathway characteristics
Standards-based clearance path.

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 571
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K002197.
VERTEX SYSTEM
K002822 · Medical Positioning, Inc. · Jan 2001
CARDIO MONITOR CENTER VISION
K003392 · Shl Telemedicine International , Ltd. · Jan 2001
KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS
K001896 · Suzuken Co., Ltd. · Jan 2001
PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
K002459 · Agilent Technologies, Inc. · Nov 2000
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · Nihon Kohden America, Inc. · Nov 2000
AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES
K002074 · H&C Medical Devices Spa · Oct 2000
K002197 · CARTOUCH
Download PDF FDA Summary Cardionics, Inc.