Cleared Special

K041459 - LIFEPAK 12 DEFIBRILLATOR/MONITOR

K041459 is the FDA 510(k) clearance for LIFEPAK 12 DEFIBRILLATOR/MONITOR by Medtronic Emergency Response Systems, Inc.. It is a Class 3 Cardiovascular device (product code MKJ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K041459 · Medtronic Emergency Response Systems, Inc. · Cardiovascular device
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Jul 2004
Decision
29d
Days
Class 3
Risk

K041459 is an FDA 510(k) clearance for the LIFEPAK 12 DEFIBRILLATOR/MONITOR. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Medtronic Emergency Response Systems, Inc. (Redmond, US). The FDA issued a Cleared decision on July 1, 2004 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5310 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Medtronic Emergency Response Systems, Inc. devices

Submission Details

510(k) Number K041459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2004
Decision Date July 01, 2004
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MKJ Automated External Defibrillators (non-wearable)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.5310
Definition This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - MKJ Automated External Defibrillators (non-wearable)

All 48
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K041459.
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
K051134 · Philips Medical Systems · Sep 2005
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
K050004 · Philips Medical Systems · Feb 2005
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
K040479 · Welch Allyn, Inc. · Sep 2004
HEARTSTART MRX, MODEL M3535A
K040404 · Philips Medical Systems, Inc. · May 2004
HEARTSTART MRX, MODEL M3535A
K031187 · Philips Medical Systems · Aug 2003
PHILIPS M5066A AND M5068A
K020715 · Philips Medical Systems · Nov 2002