Cleared Traditional

K082709 - VICOR PD2I ANALYZER, VERSION 2.1

K082709 is an FDA 510(k) clearance for VICOR PD2I ANALYZER, manufactured by Vicor Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K082709 · Vicor Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
104d
Days
Class 2
Risk

K082709 is an FDA 510(k) clearance for the VICOR PD2I ANALYZER, VERSION 2.1. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Vicor Technologies, Inc. (New York, US). The FDA issued a Cleared decision on December 29, 2008 after a review of 104 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 - K082709

510(k) Number K082709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2008
Decision Date December 29, 2008
Days to Decision 104 days
Submission Type Traditional
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
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 493
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K082709.
SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS
K090483 · Philips Medical Systems · Mar 2009
CARDITTE MICROTEL
K082124 · Et Medical Devices Spa · Feb 2009
MAC 800 RESTING ECG ANALYSIS SYSTEM
K090212 · Ge Medical Syst. Information Technologies · Feb 2009
MORTARA ELI 350 ELECTROCARDIOGRAPH
K082946 · Mortara Instrument, Inc. · Dec 2008
VICARDIO 12B
K082380 · Energy-Lab Technologies GmbH · Dec 2008
CLUE MEDICAL AND CLUE MEDICAL BASIC
K082013 · Telovital GmbH Telemedizin · Nov 2008
K082709 · VICOR PD2I ANALYZER, VERSION 2.1
Download PDF FDA Summary Vicor Technologies, I…