Cleared Special

K032926 - EKG SPEAKS

K032926 is an FDA 510(k) clearance for EKG SPEAKS, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code KRE cleared through the Special 510(k) pathway after a 23-day FDA review.

K032926 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
23d
Days
Class 2
Risk

K032926 is an FDA 510(k) clearance for the EKG SPEAKS. Classified as Analyzer, Pacemaker Generator Function, Indirect (product code KRE), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 15, 2003 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032926

510(k) Number K032926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date October 15, 2003
Days to Decision 23 days
Submission Type Special
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
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 12
Devices cleared under the same product code (KRE) and FDA review panel - the closest regulatory comparables to K032926.
PACEART OPTIMA SYSTEM SOFTWARE
K110693 · Medtronic, Inc. · Jun 2011
CYGNUS 12 LEAD ECG MODULE
K072950 · Cygnus, LLC · Aug 2008
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
K032926 · EKG SPEAKS
Download PDF FDA Summary Medtronic Vascular