Cleared Abbreviated

K072449 - CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS

K072449 is an FDA 510(k) clearance for CP100 & 200 12-LEAD RESTING ELECTROCARD..., manufactured by Welch Allyn, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K072449 · Welch Allyn, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
90d
Days
Class 2
Risk

K072449 is an FDA 510(k) clearance for the CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on November 29, 2007 after a review of 90 days - within the typical 510(k) review window.

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 - K072449

510(k) Number K072449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2007
Decision Date November 29, 2007
Days to Decision 90 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 faster than avg
Panel avg: 125d · This submission: 90d
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 577
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K072449.
QHRV 1 - HEALTH ASSESSMENT SYSTEM
K080884 · Medtechs, LLC · Apr 2008
MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
K073625 · Ge Healthcare Systems Information Technologies · Jan 2008
PORTABLE ECSCOPE 12I
K080036 · Dyansys, Inc. · Jan 2008
THE PORTABLE ANSISCOPE
K071168 · Dyansys, Inc. · Aug 2007
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
K072217 · Nihon Kohden America, Inc. · Aug 2007
PORTABLE ECSCOPE
K072353 · Dyansys Corp · Aug 2007
K072449 · CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
Download PDF FDA Summary Welch Allyn, Inc.