Cleared Traditional

K110693 - PACEART OPTIMA SYSTEM SOFTWARE

K110693 is an FDA 510(k) clearance for PACEART OPTIMA SYSTEM SOFTWARE, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code KRE cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K110693 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
89d
Days
Class 2
Risk

K110693 is an FDA 510(k) clearance for the PACEART OPTIMA SYSTEM SOFTWARE. Classified as Analyzer, Pacemaker Generator Function, Indirect (product code KRE), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on June 8, 2011 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3640 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K110693

510(k) Number K110693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2011
Decision Date June 08, 2011
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRE Device Classification - Class 2, Special Controls

Product Code KRE Analyzer, Pacemaker Generator Function, Indirect
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3640
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 - KRE Analyzer, Pacemaker Generator Function, Indirect

All 10
Devices cleared under the same product code (KRE) and FDA review panel - the closest regulatory comparables to K110693.
CYGNUS 12 LEAD ECG MODULE
K072950 · Cygnus, LLC · Aug 2008
EKG SPEAKS
K032926 · Medtronic Vascular · Oct 2003
HPM 40 HEART PACEMAKER MONITOR
K922742 · Biotronik, GmbH & Co. · Mar 1993
PACEART CPTS-86/12
K915632 · Paceart, Inc. · Apr 1992
PACEVIEW
K895535 · Micromedical · Mar 1990
PACEMAKER FUNCTION ANALYZER
K870909 · Paceart, Inc. · Apr 1987
K110693 · PACEART OPTIMA SYSTEM SOFTWARE
Download PDF FDA Summary Medtronic, Inc.