Cleared Traditional

KODEX – EPD™ System 1.5.0 (K212493) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212493 · Philips Medical Systems Nederland, B.V. (Pmsn) · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
441d
Days
Class 2
Risk

K212493 is an FDA 510(k) clearance for the KODEX – EPD™ System 1.5.0. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland, B.V. (Pmsn) (Best Noord-Brabant, NL). The FDA issued a Cleared decision on October 24, 2022 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Philips Medical Systems Nederland, B.V. (Pmsn) devices

Submission Details

510(k) Number K212493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2021
Decision Date October 24, 2022
Days to Decision 441 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
316d slower than avg
Panel avg: 125d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 183
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K212493.
STAR Apollo Mapping System
K220786 · Rhythm Al, Ltd. · Dec 2022
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
K221704 · Edwards Lifesciences, LLC · Nov 2022
HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
K223127 · Edwards Lifeciences, LLC · Nov 2022
AcQMap High Resolution Imaging and Mapping System
K222209 · Acutus Medical, Inc. · Oct 2022
EnSite X EP System
K221213 · Abbott · Aug 2022
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
K221112 · Biosense Webster, Inc. · Aug 2022