Cleared Traditional

INNOCOR (K051907) - FDA 510(k) Clearance

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

K051907 · Innovision A/S · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
231d
Days
Class 2
Risk

K051907 is an FDA 510(k) clearance for the INNOCOR. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Innovision A/S (Chicago, US). The FDA issued a Cleared decision on March 2, 2006 after a review of 231 days - an extended review cycle.

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 Innovision A/S devices

Submission Details

510(k) Number K051907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2005
Decision Date March 02, 2006
Days to Decision 231 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
106d slower than avg
Panel avg: 125d · This submission: 231d
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 207
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K051907.
MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
K072502 · Ge Medical Systems Information Technologies · Nov 2007
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
K070902 · St Jude Medical · May 2007
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
K061741 · Ge Healthcare · Sep 2006
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
K052976 · Ge Healthcare · Jan 2006
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
K052977 · Ge Healthcare · Nov 2005
MARS HOLTER ANALYSIS WORKSTATION
K051026 · Ge Medical Systems Information Technologies · Jul 2005