Cleared Traditional

K123217 - CARDEASCREEN

K123217 is an FDA 510(k) clearance for CARDEASCREEN, manufactured by Cardea Associates, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K123217 · Cardea Associates, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
113d
Days
Class 2
Risk

K123217 is an FDA 510(k) clearance for the CARDEASCREEN. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardea Associates, Inc. (Woodinville, US). The FDA issued a Cleared decision on February 5, 2013 after a review of 113 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K123217

510(k) Number K123217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2012
Decision Date February 05, 2013
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DPS Electrocardiograph

All 480
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K123217.
CP150 ELECTROCARDIOGRAPH
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CS-MAG II
K121825 · Biomagnetik-Park GmbH · Mar 2013
DIGITAL ELECTROCARDIOGRAPHS
K123816 · Shenzhen Biocare Electronics Co., Ltd. · Feb 2013
QT GUARD PLUS ANALYSIS SYSTEM
K120770 · Ge Medical Systems Information Technologies · Dec 2012
ALIVECOR HEART MONITOR FOR IPHONE
K122356 · AliveCor, Inc. · Nov 2012
DIGITAL ELECTROCARDIOGRAPH
K122712 · Shenzhen Biocare Electronics Co., Ltd. · Oct 2012
K123217 · CARDEASCREEN
Download PDF FDA Summary Cardea Associates, In…