Cleared Traditional

K120855 - INTELLISPACE ECG

K120855 is the FDA 510(k) clearance for INTELLISPACE ECG by Philips Health Care. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K120855 · Philips Health Care · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
100d
Days
Class 2
Risk

K120855 is an FDA 510(k) clearance for the INTELLISPACE ECG. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Philips Health Care (Thousand Oaks, US). The FDA issued a Cleared decision on June 29, 2012 after a review of 100 days - within the typical 510(k) review window.

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: 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.

View all Philips Health Care devices

Submission Details

510(k) Number K120855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2012
Decision Date June 29, 2012
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
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 245
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K120855.
EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
K132073 · St Jude Medical · Sep 2013
ENSITE VELOCITY SYSTEM
K130727 · St Jude Medical · Aug 2013
ENSITE VELOCITY SYSTEM
K130594 · St Jude Medical · May 2013
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
K120550 · Biosense Webster, Inc. · May 2012
ENSITE VELOCITY SYSTEM V.3.0
K112688 · St Jude Medical · Nov 2011
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
K111200 · Ge Healthcare · Oct 2011